Update – Prior Potential Safety Issue
Loose drive support cap
At Medtronic, we are committed to continually evaluating and improving the quality and reliability of our products and services. We are reaching out to remind you of a prior field corrective action relating to our Paradigm insulin infusion pumps.1 Since that communication, an updated version of your current pump is now available which has been redesigned to eliminate the potential safety issue, which we describe in more detail below. Please email us at Customer.Experience@medtronic.com (fastest method) or call us at 1-888-204-7616 if you are interested in having your current pump replaced with the updated version of your current pump model.
Reminder of Potential Safety Issue: LOOSE DRIVE SUPPORT CAP PROTRUDES FROM PUMP
The pump’s drive support cap holds the pump motor in place and allows the motor’s piston to press against the reservoir to deliver insulin. There have been reported incidences of this cap becoming loose, primarily in earlier generation pump designs. In rare cases, the cap may stick out from the bottom of the reservoir compartment, which can occur when the pump is damaged, for example if it is dropped. We have one report of a customer who attempted to push the cap back into place while the pump was still attached to their body. This resulted in unintended delivery of insulin and associated severe hypoglycemia.
A normal pump and a pump with a loose drive support cap are shown in the pictures below.
Cap slightly indented |
Cap sticking out |
Action Needed: Examine your pump. If the drive support cap is sticking out, as shown in the photo above, DO NOT PRESS ON THIS PORTION OF THE PUMP. Please discontinue use of the pump and contact Medtronic at 1-888-204-7616, option 1, to arrange for the pump to be replaced. During this time you will need to manage your diabetes with insulin injections, per the back- up plan provided to you by your healthcare professional. Please note your healthcare professional has also been made aware of this potential safety issue.
You can always report a concern to the FDA’s MedWatch Adverse Event Reporting program:
Online at: http://www.fda.gov/safety/medwatch/howtoreport/
Report by telephone: 1-800-FDA-1088
Fax report: 1-800-FDA-0178
Should you have any questions or concerns regarding this issue please do not hesitate to contact the Medtronic 24-Hour HelpLine at 1-888-204-7616. Your safety and complete satisfaction are our first priority and we appreciate your time and attention to this important notification.
1The model numbers of the pumps that may be affected by these issues are MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523,MMT-523K, MMT-723, MMT-723K, MMT-551, and MMT-751.
Frequently asked questions
No, if the drive support cap on your pump is not sticking out, then you don’t have to return your pump. But if you think your pump is impacted, you have the option to trade in your current pump for an updated version. The updated version is available in the black color and with a 300-unit reservoir.
Your safety and complete satisfaction are our first priority and we appreciate your time and attention to this important notification.
Should you have any questions or concerns regarding this issue, please do not hesitate to contact Medtronic:
A. Email us at Customer.Experience@medtronic.com (fastest method)
OR
B. Call us at the Medtronic 24-hour helpline at 1-888-204-7616
This is a reminder of a voluntary field notification which means that we’re choosing to notify our customers about this issue. While the FDA officially classifies all customer communications such as these as a “recall,” this voluntary field action doesn’t require you to return your pump. Your pump only needs to be returned if it has a loose drive support cap or you request a pump replacement now.
Your safety and complete satisfaction are our first priority and we appreciate your time and attention to this important notification.
Should you have any questions or concerns regarding this issue, please do not hesitate to contact Medtronic:
A. Email us at Customer.Experience@medtronic.com (fastest method)
OR
B. Call us at the Medtronic 24-hour helpline at 1-888-204-7616
This reminder notification is a follow up to our initial notification from 2013 regarding this potential safety concern. We have taken steps to make our Paradigm pumps less vulnerable to this potential safety issue. This voluntary field notification only requires products to be returned if you see signs of damage.
Because patient safety is our top priority, it’s important for us to communicate these potential issues so that our customers are aware that they exist and know what to do should they occur.
Should you have any questions or concerns regarding this issue, please do not hesitate to contact Medtronic:
A. Email us at Customer.Experience@medtronic.com (fastest method)
OR
B. Call us at the Medtronic 24-hour helpline at 1-888-204-7616
Medtronic continuously works to improve product quality and features for both new and existing products. To help address this potential issue, we have made improvements to the drive support cap (metal cap that screws into the case) and the strength of the connection. And, as part of our ongoing quality efforts, we’re continuing to look at new solutions as well.
Your safety and complete satisfaction are our first priority and we appreciate your time and attention to this important notification.
Should you have any questions or concerns regarding this issue, please do not hesitate to contact Medtronic:
Email us at Customer.Experience@medtronic.com (fastest method)
OR
B. Call us at the Medtronic 24-hour helpline at 1-888-204-7616