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Alert: Product and Safety Notice
New Year New Beginnings
A new year means new beginnings. I want to take this time to thank you for your patience with us over the last few months and share some very positive updates with you.
Product Supply Update
As many of you know, an earlier-than-expected approval of the MiniMed™ 670G system with SmartGuard™ technology, unprecedented demand for our sensors and a treacherous hurricane ripping through Puerto Rico (where our manufacturing facility is located) all contributed to inventory challenges for us in 2017. I know how much you depend on this technology. And I can only imagine how frustrating and scary shipment delays and backorders can be. I sincerely apologize to all of you who have experienced this.
Fortunately, today I have very good news to share:
- MiniMed 670G and MiniMed 630G systems are in stock and ready to meet demand.
- 99% of Priority Access orders have been fulfilled. We’ll be shipping the last few within the next month or so, barring a few exceptions for those with insurance issues (if this is you, we’ll work with you individually).
- Those who order a MiniMed 670G system today will receive both the pump and CGM starter kit as soon as we receive insurance approval.
- If you have a recent order of Guardian Sensor 3 sensors, you should see no more than a 2-3 day delay as we catch up on existing orders.
- Enlite™ sensors are available and you should not experience order delays
Want to learn more about the dedicated team in Puerto Rico working through the aftermath of Hurricane Maria to deliver your diabetes supplies? <<Click here>>>I’d also like to thank our dedicated team in Puerto Rico who have been working incredibly hard to upgrade our facility and processes to help prevent future shortages – even while enduring many personal losses as a result of Hurricane Maria. Homes destroyed and without power or water, they showed up to work (without being asked) because of their commitment to you.
Expanded Financial Assistance Options
We continue to hear from you about how diabetes takes both an emotional and a financial toll on families with diabetes. Bringing forward innovation like the MiniMed 670G system to improve the lives of people with diabetes does require considerable investment. But we want to try to do what we can, when we can, to alleviate some of the financial burden of this disease. Here are a few new options we’ve introduced to help.
- Extended Payment Plans for as Low as $1/Day*
We now have payment plans that can distribute over 48 months to cover the co-pay for your pump, CGM starter kit and first 90 days of supplies. For many, this can be as low as $1/day. This program is available for anyone, no matter your financial situation.
- Temporary Coverage for Hard Times
Diabetes is hard and sometimes life makes it even harder. When it does, we’re here to help. We have special programs for special situations such as unemployment with the last 12 months, a gap in insurance coverage due to a pre-existing condition, multiple pumpers in one household and permanent disability.
The last thing I want is for finances to stand in the way of you having access to technology that could help you live a fuller, healthier life. If you’re interested in a new system or have found yourself having difficulty affording your supplies, we do want to work with you and may have even more financial assistance programs for you, depending on your situation. Please call us at 800.646.4633 option 4 so our team can see how we can help.
Customer Service Update
Unfortunately, the supply issues and product demand also put a lot of pressure on our customer care teams. I know that call hold times have been longer than typical, and call-backs are taking us more time than they should. This is not acceptable and my team and I hold ourselves to a higher standard.
To address this issue, we’ve staffed up our teams, streamlined processes and introduced programs like text message ordering and a new online store to make it easier for you to get what you need from us. Looking for ways to improve our customer care an ongoing effort, and it’s an area of particular focus for us right now. We are committed to providing you the best possible experience. You can hear from some of the employees working diligently to meet your expectations here.
You can hear from some of employees here.
2018 Outlook
Want to hear more inspiring stories of people like you living with diabetes? <<Click here>>I feel very positive about the year ahead. We’re still working through some challenges, but we’ve taken significant steps to address them. We are, as always, incredibly inspired by you and the amazing lives you live with diabetes. I can’t wait for more of you to experience the MiniMed 670G system and look forward to your feedback. Your thoughts and experiences are so important to me and to the entire company. I’m listening and I’m Inspired by You
*No credit check required. Based on plan of 48 months.Individual plans vary.
IMPORTANT SAFETY INFORMATION
The Medtronic MiniMed 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons, fourteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 670G system includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. The system requires a prescription. The Guardian Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required.
A confirmatory finger stick test via the CONTOUR®NEXT LINK 2.4 blood glucose meter is required prior to making adjustments to diabetes therapy. All therapy adjustments should be based on measurements obtained using the CONTOUR®NEXT LINK 2.4 blood glucose meter and not on values provided by the Guardian Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the CONTOUR®NEXT LINK 2.4 blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an Alternative Site (palm) or from a control solution test. It is also not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode.
Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the 670G system has not been studied in pregnant women. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult http://www.medtronicdiabetes.com/important-safety-information#minimed-670g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library
Related Post
About Author
Louis Dias
Chief Patient OfficerLouis Dias joined Medtronic Diabetes as our Chief Patient Officer in July 2015. Louis is responsible for putting patients’ voice at the center of all our business processes – from product development to customer service and everything in between. He brings more than 20 years of experience in customer insights, marketing strategy and innovation for companies like Johnson & Johnson Vision Care and Procter & Gamble.
Originally from Portugal, Louis earned a B.S. in Chemical Engineering from the University of Houston. He is fluent in French, German, Portuguese and Spanish. He loves sardines, sports (especially soccer), outdoor activities and spending time with his beautiful family – he and his wife Heather are proud parents of a son and two daughters.
Do you know when the multi-diagonal belt clip will be available for the 670G pump?
Donna, thanks for reaching out. When I first started at Medtronic, I wore a pump (with saline) and quickly realized how much we need better belt clips and accessories! While we made some updates about a year ago, I know we’re not there yet. We have a team working hard on not only a belt clip, but a holster which will likely come sooner. The good thing about the holster is that it will protect your pump and will be multi-diagonal since I do realize you can’t twist your head upside down to read your pump . Personally, based on my experience from wearing the pump, I would choose the holster. As soon as we have updates to the availability, we will let patients know. In the meantime, maybe take a look at our newly designed website here http://bit.ly/2BfbDd2. We have a few more cases and accessories you might like.
I have been a Medtronic user for 8 years now. I am currently on the 670g in Automode. I love the system, it has helped me tremendously. I was on a 723 for 7 of those 8 years. I have experienced and have seen others from around the world with these two issues. The first issue is the center button on the 600 series pumps. Why are they cracking (I can supply pictures from different users). Second issue is the clip design on the 600 series pumps. Not just the pin falling out of the hinge on clip ,but the tracks the clip slides and locks into. This design has a major flaw. I also have experienced and have seen multiple users from around the world (I can supply photos) with the broken tracks. Another concern I have is getting the pump replaced. Since being in Automode for the last 100 days my pump has what it needs to stay in Automode. When I get a replacement pump I have to go back into Manual mode for 48 hours. Pretty much a reset. My Automode settings are completely different from manual mode and were not saved. So the adjusting goes back into effect. Will there be a way to transfer the data from pump to pump for replacement purposes?
Thanks for commenting, Brian. Glad to hear that Auto Mode has been such a help to you. We’ve had a lot of positive comments from other folks, which I’m extremely pleased with. But I’m sorry you’re having trouble with buttons and the rails on the clip. If you have photos and more information, please do email them to my team at dhelp@medtronic.com so they can share with me and with our 24-Hour HelpLine who investigates these types of issues. We take them very seriously and really appreciate your input. We are also working on a new holster for the 600 series pumps, which I believe will also help with the issues of the rails. Once that’s available we will of course, let our patients know.
You’re right that, at this time, Auto Mode settings cannot be transferred when you replace your pump. I have heard similar feedback from others that this is frustrating, given that it takes the pump some time to learn your body when you start on Auto Mode so it’s something we’re looking into. Of course, we’re also always working to try to reduce the need for pump replacements. Thanks again for reaching out.
Where are you on getting Medicare approval for your CGM? I turn 65 in May and may need to discontinue use or change brands because of the cost.
Sharlyn, I’ve met with a lot of people in your same position and do realize how big of an impact this is. We are working with the Centers for Medicaid and Medicare Services, but don’t have a time frame to share. Of course, as soon as we have an update we will make sure to let you and the community know.
Any more word on Medicare approval for 670 g CGM sensors? We lost our Medicare Advantage insurance and now have a Medicare supplement – so no coverage for the sensors. I can’t afford them on my own.
Thank you for reaching out, Norma. My team and I understand how important CGM can be to your diabetes management routine. Everyone’s financial situation is different, and we never want cost to be a barrier. This is why we have expanded our financial assistance program to include several new options, some for as little as $1 a day. Please give our Financial Assistance team a call at 800.646.4633 option #4 to discuss your eligibility.
Will 2018 offer your existing customers that have been with Medtronic for over 25 years a better option than $3,100 to upgrade to a 670 when their current pump is still in warranty? Pretty disappointed that something more affordable hasn’t been done for your existing customers that have stayed dedicated to Medtronic.
Michelle, it sounds like you’re still in-warranty on your current pump, is that right? I appreciate that you’ve been a loyal customer for the past 25 years and can certainly understand your frustration. We do work hard at putting together programs that will allow as many patients as possible to upgrade to the latest technology. At this point we’re still looking to see how we can upgrade a customer like you, because I do understand you deserve it. If we are able to provide any updates, we will of course make sure to update the community. In the meantime, if you’d like to look into payment plan options, please email my team at dhelp@medtronic.com. Thank you again for being such a loyal customer.
This all sounds great, and so far the 670g has been amazing for control of my diabetes.
But for the first time ever, and I have been a pump customer for many years, the quicksets are on back order. What? Quicksets that I have been using with at least the last 4 different pumps? This is very disappointing and really unacceptable.
Margaret, I definitely understand your frustration and do agree that this is unacceptable. We’re working very hard to do better. We have been experiencing temporary backorders on Quick-sets, but we’re working with our suppliers to address this as quickly as possible and should have restored inventory in the coming weeks. I know that changing infusion sets is not something everyone wants to do, but if you’re interested in trying another set, please email dhelp@medtronic to let my team know. They’ll look into your account and see what we can do to help.
Thank you Louis – your words are strong and meaningful to me and many other T1s. Let’s collectively hope that your company’s actions in 2018 will follow your vision here. Medtronic makes an obscene amount of money on the treatment of diabetes – it cannot be denied. Perhaps you should consider lessening the financial burden to the T1 in the United States that your products demand, as an action that would demonstrate your commitment to this cause. I realize it isn’t just you – corporate America is a complex place to exist. I know. I live there. But you and your organization must realize that you are crushing the financial security of many US T1s with your exorbitant profits. Your technology and your products are excellent. Is it really necessary to make the enormous profit margins you capture on these items? A stronger sense of community may indeed bring even greater rewards than those of your company’s current financial goals. Thank you for this opportunity. I welcome your response.
William Baum
T1 47 years
Medtronic / Minimed pump user 20 years
Human 54 years
William, I can definitely understand that diabetes is not easy and causes a great financial burden. We have many employees who also have diabetes or loved ones with diabetes who continuously express to me the emotional and financial burdens that come with it. Please know this is close to my heart and is not lost on our ears. Included in the cost of the products you receive is also the extensive customer service that we provide. We have over 1,000 members in our customer support teams, extensive training programs like StartRight, research and development for new products, putting those products into clinical trials and complex payer systems, etc. Please know I hear you, but we are also working to make sure that we can bring you the best therapies and services available.
Please let us know when we as parents will be able to monitor our children via the cloud. Please tell me your connect team is on it.
Benny, thanks so much for connecting with us. Our development team is absolutely working on bringing features that allow our customers and their loved ones to view pump and CGM data on internet connected devices. Our community has made it clear that is important to them and we look forward to bringing this technology to our products. We did receive approval of the MiniMed 670G system sooner than anticipated and unfortunately with that came trade-offs. So, while we’re working on it, I don’t have a timeline to share at this time. I wish I could make this go faster to provide parents like you the care, comfort and confidence you need and look forward to doing so in the future.
Thank you for your response. I love the 670g. It has stopped the urgent lows and we go full auto on our daughter next week. Before the 670 we had a different CGM. We have come to find that a team is better than an individual in monitoring( my wife and I and maybe another relative) it is redundant I know but we had an incident where I was at work and alarms were mistakenly shut off except for mine and it was scary….ambulance was called and she was caught at 35 and ok. I love the 670g and look forward to implementation from the connect team. I know that it will be top notch when it gets here. Wouldn’t expect any less from you all. Thanks again!
Benny, thanks for your confidence in our team and sharing this story with me. We’re working hard to make this happen as soon as possible and nothing would make us happier than to deliver this to your family. As soon as we have an update, we’ll make sure to share it. Thanks again for reaching out to me.
Dear Mr Dias,
I am an Animas pump user. I was notified in September that Medtronic would be contacting me within 69 days to discuss my transition to a Medtronic pump (not sure if eligible for 670 but would pay for the extra cost. If you could let me know where I stand it would give me great peace of mind.
Sincerely
Wayne Schwartz
Welcome to the Medtronic family, Wayne! We are still finalizing the details and processes for the Animas upgrade program, which allows for customers in warranty on or after September 30, 2019 to upgrade to the MiniMed 630G insulin pump at no charge. We will begin reaching out to customers in May to begin those conversations. However, if you are interested in our Switch2System program, you can begin the process to upgrade to the MiniMed 670G system now. If you email my team at dhelp@medtronic.com, with your contact information, they can help get you connected with our specialists.
I cannot even use my existing 670G due to lack of supplies and my outstanding order. My comment was not placed here so that is why I am replying. here
Baris, glad we were able to talk on the phone last week and that Rueben was able to get you taken care of with your sensors. If you need anything in the future, please let me know.
Any update on when remote access to BG will be available on iOS devices?
Steve, I understand this is an important feature. I’ve met with many people who have told me that this is a big deal. Please know that our development team is working on this. Unfortunately, I don’t have a timeline to share at this time. As I mentioned to Benny above, I wish I could make this go faster and really look forward to making this available in the future.
This is not true. I placed an order for Guardian sensors on December 28, received notification on January 10 that I would be receiving them in approximately two weeks. Still haven’t received them. Contacted customer service and was told that the only information that they had was that the sensors were on back order. Log on to my home on the Medtronic website, and find out that my order for sensors was changed to 1/17. This makes no sense since I received notification a week before that stating that they would be coming soon. Contact customer service and find out that my order was split and the piece for the sensors wasn’t re-entered until 1/17. Now, I’m without supplies and without answers on when I will even be receiving them. I’m very disappointed with the inefficiency regarding my orders.
Sarah, I appreciate you sharing your experience. I understand the delays can be frustrating and know our teams are working as quickly as possible to fulfill orders. I had my team take a look at your account and I’m happy to report that your Guardian Sensor 3 sensors were delivered today. Moving forward supply constraints should not cause a delay in the delivery of a transmitter or sensors.
Are you able to give those of us in Europe and in particular the UK any idea about when the 670g might become available and also whether there will be an upgrade programme for people on an Animas pump which is still under warranty?
Rosemary, I do know that people outside the US are eager to get the MiniMed 670G system. We are working with the appropriate regulatory bodies for approval around the world. At this time I don’t have an update on availability or potential programs in place but I know my team is working hard at developing things and will of course update you all once we have something to share.
Went to get the 670g after being Type 1 for 17 years and was denied last week because of Tricare being a “renter” insurance meaning they do not pay the cost up front but instead over months. Any idea when the 670 might be available for those of us with government insurance in this situation? 🙂
Savannah, I’d like to have my team look into this for you. If you could send your contact information to dhelp@medtronic.com, we’ll take a look and have someone reach out to you with an update. Thank you for reaching out and bringing this to my attention. Please let me know how things go.
Have been a T1 for 40 years and a satisfied Medtronic user for 18 years. Currently using a 530. I was super excited when publicity started on the 670. And then, found out the target. Currently I am a low-carb eater and have consistently kept my A1c below 5.5 (last A1c was 4.8), and quickly realized that going on the 670 would raise this by a lot. Backward steps for me.
Are there any plans to allow more customer flexibility? Target of 120 is high—and I consider 180 ridiculous! I shoot for 83/84, a normal healthy persons BG. I realize there is a liability factor for Medtronic with lower BG target, but the fact of the matter with low carb eaters, we seldom have violent hypoglycemia because we always have small amounts of insulin on board. Before low carb, I averaged medical intervention once every year or so; in the past 2 1/2 years have never needed intervention, but able to handle it by myself.
I realize Low Carb is not for everyone, but would urge Medtronic to be a little more flexible in its targets. Thanks.
Thanks for reaching out, Colleen. Great job on your A1C, I know it’s hard work and I’m so glad to hear that you’re doing so well. I do understand that a target glucose is often a personal decision on what you’re most comfortable with. If you’d like to know more about the reason we chose the 120 mg/dL target, I recommend reading our blog article from our Chief Medical Officer, Fran Kaufman: http://bit.ly/2r4F5O3. I realize this target glucose might not be for you and I don’t want you to forget about an important feature in Manual Mode, which is our Suspend before low feature, something like this might be of value to you or others who Auto Mode will not work well for. We have heard feedback like yours and we’re working on what’s next and taking into consideration the 120 mg/dL target. At this time I can’t comment on the target range for future generation systems.
Thank you for sharing your story with me, it’s very much appreciated and allows me to better understand the diverse patients who we serve.
I am currently trying very hard to adjust to the 670G. I too am a low carb eater and have worked hard at maintaining my glucose levels at a lower level. Automode as it is currently configured is affecting my quality of life. A lower target range would be wonderful! Sign me up for that, but not these 180’s and up.
Received my pump on January 26, 2018 and was told that I’d get a transmitter and sensors with the pump. I’m still waiting on the transmitter and sensors….because there’s yet another backlog (odd that I was told it would ship with the pump and then there was suddenly another backlog on the day the pump shipped). Nobody seems to know when anything will be shipped. I was told the backlog was 2 weeks. It’s been more than 2 weeks now. What is the current situation with transmitters and sensors? I feel like I might not be getting the whole story. If it’s April, fine, just say that. If it’s May, fine, just say that…..it’s frustrating to call and play phone tag just to be told “We don’t know”.
Elizabeth, I understand your frustration and apologize if you received any runaround from our team. From my understanding, there is a 2-3 day delay for Guardian Sensor 3 shipments, but I’d like to have my team review your account to check on the status of your CGM. If you send your full name and phone number associated with your account to dhelp@medtronic.com, we’ll take a look and get an update for you. I appreciate you sharing these concerns with me and for your patience.
Lies! Lies! Lies! Such a feel good blog post. Your company even had the nerve to send me an email on 2/28/18 saying my Priority Access order is shipping and should be received in approximately 14 days. So I call on 3/15/18 to check on that and am told by one person that the order is still in process and a second person says it is shipping, even possibly that day. I still have not received veined any confirmation of shipping. Every time I call, I get the run around. I am supposedly one of a handful of orders that haven’t been filled in Indiana and have Brennan told that for over a month. I have lost all faith in you!!!
I certainly understand, Michele. I was able to locate your account and understand your order has shipped. I know the delays have been frustrating and I assure you we recognize the challenges and are committed to doing better. If you still have concerns or would like to discuss your experience, send us an email at dhelp@medtronic.com and I’ll get you connected with a teammate.
Why has the Data Export (CSV) Feature on Carelink Personal for 670g been discontinued?
I would like the capability to export raw text data (comma separated values, or other text format) from my 670g pump. I have some excel spreadsheets I’ve made to help me monitor my blood-sugars, and run some time-series analysis to help me tweak my carb-ratio(s), basal rates, and insulin sensitivity(s). I know the preset basal settings are not as critical now we have some closed-loop control, but I would still like the capability to export data from Carelink Personal in textual form. Don’t get me wrong, the reports generated are pretty, but I want to run my own data analysis on the raw data, and if I can’t export the data from Carelink, I can’t do that anymore.
I don’t think it is to unreasonable to ask for access to my own blood-sugar, carb intake, and insulin dose data in an easy to analyze, non-graphical, format. I would contend, I have a legal right to such personal health data collected by the 670g system and Contour Next glucose meter.
I would hope Medronic will do the right thing, and continue to provide a Data Export (CSV) option for the 670g system for those of us who rely on this functionality to better manage our Type 1 diabetes.
If there is anything you can do about this, I would really appreciate it.
Jess, we agree that blood-sugar, carb intake, and insulin dose data is helpful, but the CSV file contains a lot of other data that can be misinterpreted, is more internal diagnostics, and ultimately makes it difficult to read. We are evaluating a better way to provide the raw data so that it’s more useful and usable.
I have been a loyal Medtronic user since 2001 with my very first insulin pump/ now, 17 years later I have the paradigm pump with Enlite sensor, and am on Medicare since becoming disabled by this horrible disease diabetes. To my point, until this past fall, I was able to find some other method, i.e. spouses’ insurance, COBRA, Financial Assistance from Medtronic, to finance the sensors. The updated financial assistance forms contained wording regarding having Medicare as being a reason for not meeting criteria, so I choose to purchase 1 box of sensors from Medtronics, get the denial from Medicare & appeal it. I wrote the appeal including everything I knew they needed to approve the CGM on a one case basis. I am hypoglycemic unaware. I sent Carelink reports, Doctor Progress notes, the works. Still the denial came today. It has been 3 months since you mentioned working with the Medicare & Medicaid Services to get the 670G approved for patients like me who desperately need it. I cannot feel when my blood sugar drops from 340 to 40 in 1 hour. I pass out. I don’t want to leave Medtronics. I need for YOU to advocate for ME.
Barbara, I can certainly understand your frustration. We have been working on establishing coverage for our CGM for many years and will continue to do so until our CGM is an approved benefit. At this time, we are working with the FDA for updated labeling, which is the next step towards the Centers for Medicare and Medicaid Services coverage. Unfortunately, we don’t have a timeline to share, but we will provide updates as they are available. We appreciate your patience.
I have a 530G and the warranty expires in 10 months. What is the optimal time to start the process to upgrade? Can I upgrade to the 670G directly?
Adrienne, thanks for checking in! We can start the upgrade process once your current device is out of warranty. You can reach out device specialist at 800.646.4633, option 3 to discuss your options. And yes, you do have the option to upgrade directly to the MiniMed 670G system. We look forward to hearing from you.