Loose Drive Support Cap and Potential for Water Damage

The letter you received was to tell you about two potential issues relating to Paradigm insulin pumps: a loose drive support cap and a reminder on the potential for water damage.

Some customers have experienced a loose drive support cap, and in rare cases the cap may stick out from the side of the insulin pump as a result of impact with a hard surface. In most cases, the loose drive support cap will result in an A33 or Motor Error Alarm during the manual prime/fill tubing process.

While the risk to you is low, we’re asking you to examine the drive support cap on your insulin pump. To locate the drive support cap:

• Hold the insulin pump with the screen facing you (the reservoir opening should be on the bottom of the left side.)
• The drive support cap is the round circle on the right side of the pump below the raised Medtronic MiniMed bumper label. IMPORTANT: DO NOT PRESS ON THIS PORTION OF THE INSULIN PUMP.
• A normal insulin pump and an insulin pump with a loose drive support cap are shown in the pictures below.
• Look at the drive support cap:
  • If drive support cap IS NOT indented: You must discontinue use of the insulin pump.You will need to manage your diabetes with insulin injections, per the back-up plan provided to you by your healthcare professional.
  • If drive support cap IS indented: Your drive support cap has not been impacted and you can continue to use your insulin pump. Continue to monitor your insulin pump for signs of damage and contact us 24 hours a day at 1.888.204.7616 option 1 if you notice any changes in your drive support cap.

If needed, refer to the photo below, which also appears in the customer notification letter.

No. Only damaged pumps need to be returned. Because the safety of customers like you is our top priority, it is important for Medtronic to communicate these potential issues so that you are aware that they exist and know what to do should you suspect there is an issue.

You only need to send your insulin pump back if the drive support cap is loose (sticking out or flush with the side of your insulin pump) or if you have experienced another malfunction.

All Paradigm insulin pump models may be affected. You can find the insulin pump model in the status screen or the insulin pump label. This link can also help you find your pump model.

The model numbers of the pumps that may be affected by these issues are MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754.

In most cases you will get an A33 or Motor Error Alarm during the manual prime/fill tubing process. In rare occasions the insulin pump may not alarm during the manual prime/fill tubing process. Because the safety of customers like you is our top priority, we are advising you to determine whether the drive support cap is dislodged by examining your insulin pump. You should not rely on the alarm to determine whether the cap is loose or dislodged. Please note that an A33 alarm is not incorporated in model 511/711 or 512/712 Paradigm insulin pumps.

To check for damage associated with loose drive support cap follow this process:

1. Check that all connections are still tightly in place.
2. If you notice that the drive support cap is loose, or sticking out, discontinue use of the pump. Do not press on the drive support cap. Pushing on the drive support cap may result in unintended insulin delivery, which can cause hypoglycemia.
3. Check the LCD, keypad and pump case for cracks or damage.
4. Check the infusion set, including the tubing connector and tubing cracks or damage.
5. Review the status screen, basal rates, and other pump settings.
6. Perform the Selftest procedure located in the UTILITIES MENU.
7. If the selftest does not complete successfully, call our 24-Hour HelpLine for assistance.

Your insulin pump is designed to resist accidental contact with liquids which includes insulin as well as water. If your insulin pump has been exposed to insulin, follow the same steps you would if it was accidentally exposed to water:

1. Pat the outside of the case until dry.
2. Open the reservoir compartment and check the compartment and reservoir for water. If wet, dry it completely within 10 minutes of exposure to water. Exposure to liquids, including water or insulin can corrode the mechanism.
3. Dry the reservoir completely—do NOT place a wet reservoir in the insulin pump.
4. Do not use hot air to dry your insulin pump. This may damage your insulin pump's internal electronics.
5. Check the battery compartment and the battery—if wet, let them dry completely before using the insulin pump.
6. Perform a Self-test procedure located in the utilities menu.

We have always stated in our user guide and in a variety of customer communications that you should avoid exposing insulin pumps to water. As summer is approaching, we are using this notification as a value added reminder.

Yes, in addition to notifying our customers, we are sending letters to doctors and certified product educators as well.

If you have inspected your insulin pump and believe there is an issue, please notify Medtronic directly. If there is an issue, you will be asked to return your product directly to us. We have notified distributors so that they are aware of this situation as well.