FDA recalls insulin pump responsible for 1 death, thousands of injuries
Malfunction causes improper amount of insulin to be delivered
An insulin pump commonly used by people diagnosed with Type 1 diabetes that caused a death and more than 2,000 injuries has been recalled due to a malfunction, according to the U.S. Food and Drug Administration.
Medtronic has pulled its MiniMed Insulin Pumps as part of a Class I recall, which is the most serious type.
According to the agency, a retainer ring designed to lock the insulin cartridge in place in the pump’s reservoir compartment can break, meaning the device could deliver too much or not enough insulin.
Pump users could suffer from hypoglycemia or hyperglycemia if they don’t receive the correct amount of insulin. Severe cases of hyperglycemia can lead to loss of consciousness, seizure and death.
Officials said they have received 26,421 complaints about the device, which includes one death and 2,175 injuries.
The affected models are:
- MiniMed 600 Series Insulin Pumps
- Model 630G (MMT-1715) - all lots before October 2019
- Model 670G (MMT-1780) - all lots before August 2019
- Distribution Dates
- Model 630G - September 2016 to October 2019
- Model 670G - June 2017 to August 2019
More than 322,000 devices have been recalled since November 2019.
The FDA asks that anyone in possession of one of the pumps take the following precautions:
- Examine the retainer ring of the 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 doctor’s 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.
Anyone with questions about their device should call Medtronic Technical Support at 877-585-0166. More information can also be found here.
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