MINIMED PARADIGM 530G AND MINIMED REVEL INSULIN PUMP NEW SALES.


As we advance our diabetes technology, we have decided to discontinue the sale of new MiniMed™ Revel™ and MiniMed™ 530G pumps by October 26th, 2018. Please know we are committed to ensuring patients have what they need to manage their diabetes on their current pump, and our level of service will not change. We will continue to offer 24-hour helpline support for troubleshooting and will continue to offer infusion sets and reservoirs to support current customers with their therapy needs.

  • Our 24-hour helpline will continue to assist with troubleshooting needs.
  • Our Supply Management Team will continue to support supply reorders, including: infusion sets, reservoirs (1.8mL and 3.0mL reservoirs) and sensors.

Moving forward, our pump options include the MiniMed 670G pumps and MiniMed™ 630G pumps. Both of our latest product offerings are paired with our most advanced sensor, the Guardian sensor 3.

MiniMed 630G System

MiniMed 670G System

Although we encourage customers to experience our most advanced diabetes technologies, we will continue to offer the MiniMed 530G pump and the MiniMed Revel pump through October 26th, 2018 (while supplies last).

 

OUT-OF-WARRANTY MEDTRONIC CUSTOMERS


We will continue to offer 24-hour helpline support for troubleshooting and will continue to offer infusion sets and reservoirs to support current customers with their therapy needs.

Eligible out-of-warranty Medtronic customers may be eligible for our Pump Trade-in Program, which allows for the return of the current insulin pump for a $500 Medtronic account credit when a new pump has been purchased.* To check your eligibility and consider our newest MiniMed insulin pump technology, call us at 866-469-5459 or text “Paradigm" to 70604.

 

IN-WARRANTY MEDTRONIC CUSTOMERS


Medtronic will continue to provide in warranty product support and warranty replacements as originally planned through the full term of your warranty. We will continue to offer 24-hour helpline support for troubleshooting and will continue to offer infusion sets and reservoirs to support current customers with their therapy needs.

 

Q&A


General Q&A


Which pumps are impacted?

All MiniMed Paradigm model pumps including all size and color variants of the following pump series:

  • MiniMed Revel pumps
  • MiniMed 530G pumps


Will you continue to offer MiniMed Paradigm supplies?

We will continue to offer MiniMed Paradigm infusion sets and reservoirs.

Will you continue to offer MiniMed Paradigm accessories?

We will continue to provide replacement belt clips and battery caps.

Will you still offer the Travel Loaner Program?

We will continue to provide the Travel Loaner Program. Customers will receive a MiniMed Paradigm pump (MiniMed 530G 751 or MiniMed Revel 723).

 

In-Warranty Customer Q&A


I’m in warranty and my pump broke. I need a replacement pump. What do I do?

Thank you for being a valued Medtronic customer. Please contact our 24-hour helpline for support. Replacement pumps will be available if needed. Please note that customers with 5 series pumps will be provided a 7 series replacement pump. Also, pumps will only come in the smoke color.

Will you still offer the Travel Loaner Program?

We will continue to provide the Travel Loaner Program. Customers will receive a MiniMed Paradigm pump (MMT-751L or MMT-723L).

I’m in warranty and my 1.8mL pump broke. I want the same exact model for my replacement?

Thank you for being a valued Medtronic customer. We have recently consolidated our MiniMed Paradigm pump offering, and no longer manufacture MiniMed Paradigm pumps in the 1.8mL size reservoir pump. As you are still in warranty, we will replace your pump with a Smoke/3mL version of your current model pump.

I’m in warranty and my clear/blue/pink/purple pump broke. I want the same exact model for my replacement?

Thank you for being a valued Medtronic customer. We have recently consolidated our MiniMed Paradigm pump offering, and no longer manufacture MiniMed Paradigm pumps in the colors clear, blue, pink, and purple, as well as the 1.8mL size reservoir pump. As you are still in warranty, we will replace your pump with a Smoke/3mL version of your current model pump.

What is the difference between a 1.8mL and 3mL size pump?

The main difference is the insulin reservoir size each pump can accommodate. The 3mL pump can accommodate use of either a 1.8mL or 3mL size reservoir, best meeting the needs of more patients. The 3mL pump is 0.4 inches longer than the 1.8mL pump.

If I get the 3mL pump, will I still be able to use my 1.8mL reservoirs?

Yes, you can continue to use your 1.8mL reservoirs. However, since the reservoir only holds 180 units of insulin, the reservoir icon will not appear full even when the 1.8mL reservoir is full. You can still personalize your low reservoir warning to your needs. It is important that you fill your reservoir with the amount of insulin that you will need for 2-3 days per your insulin needs. Based on your total daily dose (TDD), your providers can determine the appropriate size reservoir and volume of insulin.

 

Out-Of-Warranty Customer Q&A


My pump just broke and I want to upgrade - do you have a pump I can use in the interim?

Yes, we have a Continuation of Therapy Program which loans you a pump while we work to process your new pump order.

I would like to get another MiniMed Revel pump or MiniMed 530G pump. Do you still have any?

Yes, there will be limited quantities of the MiniMed Revel and MiniMed 530G pumps on hand through October 26th, 2018 (while supplies last).

*Pump Trade-in
–  This program is only available for out-of-warranty MiniMed™ insulin pump customers
–  Failure to return your old MiniMed™ pump will disqualify you for the $500 Pump Trade-in Program credit, and you will be responsible for the full cost of the Medtronic pump.

Important Safety Information: MiniMed 670G System
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, seven 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 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.

WARNING: Medtronic performed an evaluation of the MiniMed 670G system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.

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 MiniMed 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.

Important Safety Information: MiniMed 630G System with SmartGuard Technology
The MiniMed 630G system with SmartGuard technology requires a prescription. It is intended for continuous delivery of basal insulin and administration of insulin boluses for the management of diabetes mellitus in persons 14 years of age or older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The SmartGuard feature allows one to program the pump to temporarily suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value. The MiniMed 630G system is not intended to be used directly for making therapy adjustments or preventing or treating hypoglycemia. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare professional. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter (BGM). A confirmatory finger stick test via the CONTOUR®NEXT LINK 2.4 blood glucose meter is required prior to making adjustments to diabetes therapy. Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the CONTOUR®NEXT LINK 2.4 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 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 who are unwilling or unable to perform a minimum of four blood glucose tests per day, or who are unwilling or unable to maintain contact with their healthcare professional, or whose vision or hearing does not allow recognition of pump signals and alarms. Insulin pumps use U100 rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately.

WARNING: The SmartGuard Suspend on low feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the SmartGuard Suspend on low feature, it is important to read the SmartGuard Suspend on low information in the Getting Started Guide and the MiniMed 630G System User Guide and discuss proper use of the SmartGuard Suspend on low feature with your healthcare provider.

Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. Please visit www.medtronicdiabetes.com/importantsafetyinformation for more details.

The CONTOUR®NEXT LINK 2.4 Meter is used with the MiniMed 630G system.

Important Safety Information: MiniMed 530G System with SmartGuard Technology
Indications for Use
The MiniMed 530G 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 diabetes mellitus in persons, sixteen 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 530G system can be programmed to automatically suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value.

The MiniMed 530G system consists of the following devices that can be used in combination or individually: MiniMed 530G insulin pump, Enlite sensor, Enlite serter, the MiniLink Real-Time transmitter, Bayer’s CONTOUR®NEXT LINK wireless meter, CareLink Pro therapy management software for diabetes, and CareLink Personal therapy management software for diabetes. The system requires a prescription.

The MiniMed 530G system is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 530G system. The MiniMed 530G system is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm to take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.

WARNING: The Threshold Suspend feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the Threshold Suspend feature, it is important to read the Threshold Suspend information in the Getting Started Guide and the MiniMed 530G System User Guide and discuss proper use of the Threshold Suspend feature with your healthcare provider.

Contraindications
Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day.

Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms.

See Instructions for Use (IFU) for additional details. http://www.medtronicdiabetes.com/download-library/minimed-530g

MiniMed Paradigm REAL-Time Revel Insulin Pump
The Paradigm REAL-Time Revel insulin pumps (MMT-523/MMT-723) are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Paradigm REAL-Time Revel system consists of the Paradigm MMT-523/MMT-723 insulin pumps, the Enlite glucose sensor (MMT-7008), and the MiniLink Transmitter (MMT-7703). Use of the Paradigm MMT-523/MMT-723 insulin pumps with the optional sensor and transmitter components is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (ages 18 and older).

Enlite Sensor
The Enlite sensor (MMT-7008) is intended for use with the Paradigm REAL-Time Revel insulin pump systems (MMT-523/MMT-723) to continuously monitor glucose levels in persons with diabetes. Glucose values provided by the Paradigm REAL-Time Revel system are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on the sensor glucose readings provided by the Paradigm REAL-Time Revel system.

Meter
The Paradigm pump can be programmed to receive fingerstick blood glucose values transmitted from Bayer's CONTOUR®NEXT LINK Wireless Meter for use in the Bolus Wizard calculator and for use as calibration values for the glucose sensor. Glucose values from other glucose meters must be manually entered into the pump. For additional details, including warnings, precautions, and contraindications, please consult the product user guide at http://www.medtronicdiabetes.com/download-library/minimed-revel.

MiniMed is a registered trademark and SmartGuard is a trademark of Medtronic, MiniMed Inc.

940M19098-011 20JUL2018 © 2018 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Ascensia, the Ascensia Diabetes Care logo, and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care.