In November of 2019, the U.S. Food and Drug Administration (FDA) announced a Class I recall of Medtronic MiniMed Insulin Pumps. The recall may affect 322,005 pumps in the U.S. and was caused by a part of the pump which may be broken or missing and may result in serious injury due to insulin over dosage or under dosage.
The affected MiniMed insulin pump uses a retainer ring to lock the cartridge or reservoir which contains the supply of insulin in place. If the retainer ring is broken or missing, the cartridge may not be properly secured which may lead to over delivery or under delivery of insulin. Such an error may result in hypoglycemia or hyperglycemia and may be life threatening.
Of the 322,005 pumps which may be affected by the recall, there have been 26,421 error reports which included 2,175 injuries and at least one death which have been received by the FDA. People or loved ones of those who were injured by a MiniMed Insulin Pump malfunction may be considering filing a lawsuit against Medtronic to seek compensation.
Medtronic Insulin Pump Recall
The FDA issued a safety alert on November 21, 2019, regarding a Class I recall for Medtronic MiniMed Insulin Pump. A Class 1 recall is the highest urgency recall which indicates that the device poses a high risk of serious injury or death.
The safety notification stated that Medtronic was recalling the devices due to a risk of inaccurate insulin dose due to the possibility of a broken or missing retainer ring on the pump. The ring is required to lock or secure the cartridge reservoir which contains the insulin supply, into place. If the retainer ring is broken, damaged or missing and the cartridge is not properly secured, the device may misdeliver insulin dose to the user. Both overdosage which may result in hypoglycemia, and underdosage which may result in hyperglycemia, are possible. Either condition may be serious or life-threatening.
The November 2019 recall may affect 322,005 devices in the U.S. and thousands more around the world. The affected models include:
- MiniMed 600 series insulin pump model 630G (MMT-1715) manufactured before October 2019
- MiniMed 600 series insulin pump model 670G (MMT-1780) manufactured before August 2019
MiniMed Recall Instructions for Patients
MiniMed insulin pumps are small drug delivery devices intended to automatically supply insulin to people who use them as a part of their diabetes management plan. Though Medtronic has had several recalls, the current threat involves a newer type of pump designed to be used as part of a “closed-loop” system which automatically detects blood glucose levels and delivers the insulin dose according to programming.
The recall affects two pumps, the 630G which is approved for patients over the age of 16 and the 670G pump, approved for patients over the age of 7 years.
Users of the 630G and 670G pumps have been advised to:
- Examine the retainer ring of the pump and discontinue using the pump if the ring appeared to be damaged, loose or missing. Discontinue using the pump if the reservoir cartridge does not lock into place.
- If pump use is discontinued, the health care provider should be contacted for manual insulin dosing instructions. Insulin should be given manually until a new pump is obtained.
- If a pump is dropped, the pump and retainer ring should be checked for damage
- The pump, retainer ring and cartridge should be checked at every set change to ensure the cartridge locks properly.
Signs of hypoglycemia include:
- Irregular heartbeat
- Loss of consciousness
Signs of hyperglycemia include:
- Extreme thirst
- Excessive urination
- Nausea and vomiting
- Shortness of breath
- Fruity odor
- Loss of consciousness
Signs or symptoms of hypoglycemia or hyperglycemia should be reported to a healthcare professional right away and treated as an emergency if severe.
Prior Medtronic Insulin Pump Recalls
Though the Medtronic MiniMed Insulin Pump recall issued in November 2019, is particularly serious and affects hundreds of thousands of people, it is not the first time Medtronic has been forced to recall their devices.
The MiniMed Pump has a long history of difficulties which have required numerous recalls over the last decade. Prior recalls have included:
- September 2019 – MiniMed pumps with remote controller recalled due to cybersecurity concerns
- June 2019 – MiniMed pump models with certain software recalled over hacking concerns
- September 2017 – MiniMed pumps recalled due to concerns over a blocked pump membrane which resulted in hypoglycemia
- September 2015 – MiniMed 620G and 640G pumps recalled due to drive motor and malfunctioning timer
- September 2014 – MiniMed Paradigm insulin pump recalled due to programming errors which had resulted in maximum insulin dose being mistakenly delivered
- July 2013 – MiniMed Paradigm reservoir recalled due to a problem with priming of the pump.
- June 2013 – MiniMed Paradigm infusion sets recalled due to pump priming issues
- 2009 – MiniMed Quickset infusion sets for the Paradigm pump recalled due to a manufacturing defect which resulted in misdosing
MiniMed Insulin Pump Recall Lawsuit
Medtronic has faced thousands of lawsuits over injuries caused by its medication pumps in the past. While most of these lawsuits were settled or resolved, the company may be facing a new round of lawsuits filed by people who have been injured by the MiniMed 630G or 670G Insulin Pump.
The FDA has received over 2,175 injury reports including at least one death involving the retaining ring issue of the MiniMed pump. Some of these people or others who were injured by the MiniMed Insulin Pump malfunction may be considering lawsuits and should seek legal assistance.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.