A hardware malfunction affecting more than 320,000 Medtronic MiniMed 600 Series Insulin Pumps has been linked to more than 26,400 consumer complaints, including 2,175 injuries and one patient death, according to a recent notice from the U.S. Food and Drug Administration (FDA). The FDA notice comes on the heels of a warning issued by Medtronic in November, and categorizes the action as a Class I recall, which means the insulin pump defect may result in serious injury or death. If you believe you have been adversely affected by side effects of Medtronic’s recalled MiniMed Insulin Pump, contact a knowledgeable product liability lawyer as soon as possible to explore your possible compensation options.
Medtronic’s MiniMed 600 Series Insulin Pump is a medical device used to deliver insulin for patients to manage their diabetes. The insulin pump is designed with a pump retainer ring that locks the reservoir in the pump, to ensure proper delivery of insulin. Unfortunately, there have been reported incidents of a loose reservoir that can no longer be properly locked into the pump, which increases the risk of under or over delivery of insulin and exposes users to serious and potentially life-threatening medical problems. According to Medtronic, the retainer ring can be broken as a result of the insulin pump being dropped or bumped on a hard surface. One of the two pumps included in the FDA recall is the Model 670G insulin pump, which garnered FDA approval in 2016 as the first automatic insulin delivery device.
In November 2019, Medtronic warned users of the insulin pump about a defect that could put them at risk for hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar). According to a letter issued by the medical device maker, “There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock.” The company warned that if the reservoir is not properly locked into the pump, users could be at risk for under or over delivery of insulin, which could result in hypoglycemia or hyperglycemia. The letter identified Medtronic’s MiniMed 630G Insulin Pump (MMT-1715) and MiniMed 670G Insulin Pump (MMT-1780) as the medical devices potentially affected by the pump retainer ring defect.
On February 12, the FDA announced a Class I recall of Medtronic’s 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.” The recall affects a total of 322,005 devices in the United States, including all 630G pumps distributed from September 2016 to October 2019, and 670G pumps distributed from June 2017 to August 2019. According to the recall announcement, the FDA has received a total of 26,241 complaints in which a Medtronic insulin pump malfunctioned because of a missing or broken retainer ring, resulting in 2,175 injuries and one death. Those who may be affected by the Medtronic insulin pump recall include any person with diabetes who uses an affected insulin pump and any healthcare providers who treat people with diabetes using an insulin pump with a missing or broken retainer ring.
The FDA is advising affected patients and healthcare providers to examine the retainer ring of their Medtronic insulin pump to determine whether the ring is working properly, and to stop using the pump if the reservoir does not lock into the pump, or if the retainer ring is loose, missing or otherwise damaged. Patients who have suffered complications such as hypoglycemia or hyperglycemia while using a recalled Medtronic insulin pump are encouraged to report the problem to MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program. Hypoglycemia and hyperglycemia are serious, potentially life-threatening medical conditions that can occur when a person’s diabetes isn’t treated properly. According to the FDA recall announcement, severe hyperglycemia can result in a loss of consciousness, seizure and death.