FDA : MiniMed 600 Series Insulin Pumps by Medtronic : Class I Recall - Due to Incorrect Insulin Dosing
A MedWatch Safety Alert was added to the FDA Medical Device Recalls webpage. Read the recall notice online.
TOPIC: MiniMed 600 Series Insulin Pumps by Medtronic: Class I Recall - Due to Incorrect Insulin Dosing
ISSUE: Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment. If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia.
The firm has received a total of 26,421 complaints in which the device malfunctioned in this manner. The firm is aware of 2,175 injuries and 1 death.
RECOMMENDATION: It is recommended that patients:
- Examine the retainer ring of their pump.
- Stop use of the pump and contact Medtronic for a replacement pump if the reservoir does not lock into the pump or if the retainer ring is loose, damaged, or missing. If you stop using the pump, you should follow your health care provider recommendations and perform manual insulin injections.
- Continue using the pump if the reservoir locks in place correctly.
- If the pump is dropped by accident, check the pump and retainer ring for damage and stop use if it is damaged.
- Check the pump retainer ring and verify that the reservoir is locked correctly at every set change.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: