Medtronic Diabetes

FREQUENTLY ASKED QUESTIONS

No. We initiated this voluntary safety notification on MiniMed™ 600 series insulin pumps in November 2019. This recent classification by the FDA does not introduce any new issues or generate new instructions for customers to return product that is working properly.

No, only insulin pumps in which the reservoir is not being locked properly in the pump because the retainer ring is loose, damaged or missing need to be returned.

Medtronic is only replacing if the retainer ring on your pump is loose, damaged or missing. If by accident you drop or bump your pump, check your pump and pump retainer ring for damage. Examine your pump retainer ring and check that your reservoir locks in place at every set change.

Yes, it may affect all the MiniMed™ 600 series insulin pumps. This safety notification does not apply to MiniMed™ Paradigm™ insulin pumps.

Please reference the ACTIONS REQUIRED section outlined in your Safety Notification.

If you are still uncertain if your pump is impacted, contact the Medtronic 24 -Hour Technical Support line to troubleshoot the device and to discuss this issue in further detail to determine if your device is impacted.

Please reference the ACTIONS REQUIRED section outlined in your Safety Notification. If you are still uncertain if your pump is impacted, contact the Medtronic 24 -Hour Technical Support line to troubleshoot the device and to discuss this issue in further detail to determine if your device is impacted.

Damage to the pump retainer ring can occur as a result of dropping or bumping your pump on hard surfaces.  By taking the necessary precautions found on your safety notice found under PRECAUTIONS RECOMMENDED FOR ALL PATIENTS, there are proactive actions that can be taken to prevent this issue from occurring.

  1. If by accident you drop or bump your pump, check your pump and retainer ring for damage.
  2. Routinely examine your pump retainer ring and check that your reservoir locks in place at every set change.

If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia. 

  • For example, if the pump retainer ring is broken or becomes detached from the pump, and the user inserts the reservoir back into the pump while the infusion set still connected to the body, it could result in a rapid infusion of insulin, which could cause hypoglycemia.  The under delivery of insulin could occur if the reservoir is not properly locked in place by the retainer ring, creating a space between the pump and the reservoir, and preventing the pump from pushing the expected insulin into the body, which could cause hyperglycemia.
If the retainer ring on your pump is not loose, damaged or missing, then we suggest you continue using your device. If you are still concerned about this issue, we recommend that you continue to use your pump and examine the locking of your reservoir and retainer ring during each reservoir and infusion set change.