The FDA announced on February 12, 2020 a Class I recall of 322,005 MiniMed 600 Series Insulin Pumps Model 630G (MMT-1715) (all lots before October 2019) and Model 670G (MMT-1780) (all lots before August 2019). The distribution dates for Model 630G were from September 2016 to October 2019, and the distribution dates for Model 670G were from June 2017 to August 2019.
People who have Type 1 diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes. The Model 630G insulin pump may be used by persons sixteen years of age and older. The Model 670G insulin pump may be used by persons fourteen years of age and older.
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. Severe hyperglycemia can result in a loss of consciousness, seizure, and death. Medtronic has received a total of 26,421 complaints in which the device malfunctioned in this manner and is aware of 2,175 injuries and 1 death.
On November 21, 2019, Medtronic notified affected customers and advised them to examine the retainer ring of their pump and to 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.
Medtronic instructed “if you stop using the pump, you should follow your doctor’s recommendations and perform manual insulin injections” and to continue using the pump if the reservoir locks in place correctly. Medtronic further instructed “if the pump is dropped by accident, check the pump and retainer ring for damage and stop use if it is damaged.” Finally, Medtronic instructed to check the pump retainer ring and verify that the reservoir is locked correctly at every set change.
Class I recall is the most serious type of recall. Use of devices subject to a Class I recall may cause serious injuries or death.
On June 27, 2019, the FDA announced that it “has become aware that an unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially connect wirelessly to a nearby MiniMed insulin pump with cybersecurity vulnerabilities. This person could change the pump’s settings to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis. Medtronic cannot update the MiniMed™ 508 and Paradigm™ insulin pump models to address these potential cybersecurity risks. As a result, the FDA recommends patients replace affected pumps with models that are better equipped to protect them from these risks. To date, the FDA is not aware of any reports of patient harm related to these potential cybersecurity risks.”
If you or a loved one suffered harm due to a defective medical device such as an insulin pump in the United States, you should promptly consult with a medical device injury lawyer in your U.S. state who may investigate your defective medical device claim for you and represent you or your loved one in a medical device claim, if appropriate.
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