Medtronic MiniMed Insulin Pump Lawsuit
The FDA has announced that they have issued a Class I recall for Medtronic MiniMed Insulin Pumps including:
- Model 630G (MMT-1715) manufactured before October 2019
- Model 670G (MMT-1780) manufactured before August 2019
The recall may affect 322,005 pumps in the U.S. The FDA says that they have received 26,421 complaints for the malfunction which may have resulted in 2,175 injuries and one death.
People who were injured by the 630G and 670G MiniMed Insulin Pumps may be considering lawsuits against Medtronic to seek compensation for their injuries.
Medtronic MiniMed Insulin Pump Recalls
On November 21, 2019, the FDA issued a Class I recall for the MiniMed pumps which warned of the potential for insulin overdose or underdose due to an improperly seated cartridge.
The devices may have a missing, damaged or broken retainer ring which is intended to lock the cartridge in place. If the ring is damaged or fails to lock the reservoir securely, insulin dosages may be inaccurate and result in serious hypo or hyperglycemia. Users of the pumps were advised to examine their pumps, stop using broken or pumps that fail to lock and to seek medical advice for continued insulin dosing or symptoms of illness.
In the past 10 years, Medtronic has been forced to issue multiple recalls for insulin pump, insulin set and insulin reservoir failures.
Medtronic MiniMed Insulin Pump Lawsuit Overview
The U.S. Food and Drug Administration (FDA) announced a Class I recall issued by medical device maker, Medtronic for its MiniMed Insulin Pumps. The November 2019 announcement reportedly affected 322,005 pumps in the U.S. and thousands more around the world.
The recall was prompted by the possibility of a broken or missing retainer ring on the pump which would allow an over delivery or under delivery of insulin to the patient. Either case is potentially harmful or even life-threatening.
The FDA has received at least 26,421 error reports including 2,175 injuries and at least one death which can be attributed to the recalled pumps. Medtronic may be facing a new round of MiniMed Insulin Pump lawsuits filed by people or loved ones of those who were injured due to the malfunction.
Medtronic MiniMed Insulin Pump Recall
A safety alert was issued by the FDA on November 21, 2019 notifying the public and the health care community of a Class I recall for the MiniMed Insulin Pump, manufactured by device maker Medtronic. Class 1 recalls are the highest safety risk and indicate that the device poses a high potential for serious injury or death.
The FDA’s announcement stated that the MiniMed pumps in question were being recalled due to the potential for a broken or missing retainer ring on the pump. The ring is intended to lock the reservoir cartridge of insulin supply into place. If the ring is missing or damaged, the cartridge may not properly lock and if loose, may over deliver or under deliver the insulin dose.
Too much insulin (over delivery) may result in hypoglycemia while too little (under delivery) may result in hyperglycemia, either of which may result in serious medical harm or be life-threatening.
The recall may affect an estimated 322,000 devices in the U.S. and includes the following MiniMed 600 series insulin pump models:
- MiniMed 630G (MMT-1715) manufactured before October 2019
- MiniMed 670G (MMT-1780) manufactured before August 2019
MiniMed Patient Instructions
The MiniMed Insulin Pump is a small drug delivery device which contains a supply of insulin to be delivered automatically to patients without requiring individual injections. The newest technology allows for a “closed-loop” system which measures the blood sugar and delivers the appropriate amount of insulin in a manner said to be an “artificial pancreas”.
The recall affects two of the most recent pumps, 630G and 670G which can be used in the automatic system. If the retainer ring that holds the insulin reservoir cartridge in place is not functioning, it may not lock securely and may result in improper insulin dosing.
Due to the recall, users of the pumps have been advised to:
- Examine the retainer ring of their pump and
- Stop using the pump if the ring appeared to be damaged or missing.
- Stop 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 may include:
- Dizziness, confusion, weakness
- Irregular heartbeat
- Seizures and/or loss of consciousness
Signs of hyperglycemia include:
- Extreme thirst and urination
- Fatigue, weakness
- Nausea and vomiting
- Shortness of breath
- Fruity odor
- Loss of consciousness
Signs of hypoglycemia or hyperglycemia should be reported to a health care provider as needed. If symptoms are severe, the condition should be treated as a medical emergency.
Medtronic Insulin Pump Recall History
The November 2019, Medtronic MiniMed Insulin Pump recall is a Class I recall, indicating that it has a high risk for potential harm, however it is not the first recall Medtronic has been forced to issue for their insulin pumps.
Other recalls have included:
- September 2019 – MiniMed pump with a remote controller recalled over cybersecurity concerns
- June 2019 – MiniMed pumps with certain software versions recalled over hacking concerns
- September 2017 – MiniMed pumps recalled due to potential for a blocked pump membrane which may result in insulin dosing error
- September 2015 – MiniMed 620G and 640G pumps recalled because of malfunctioning drive motor and malfunctioning timer
- September 2014 – MiniMed Paradigm insulin pump recalled after programming errors had resulted in maximum insulin dose being mistakenly delivered
- July 2013 – MiniMed Paradigm reservoir recalled due to a problem with priming of the pump. The prior month, MiniMed Paradigm infusion sets has been recalled due to similar priming issues
- 2009 – MiniMed Quickset infusion sets for the Paradigm pump recalled due to a manufacturing defect that had resulted in dosing errors
Filing a MiniMed Insulin Pump Recall Lawsuit
Due to a history of problems with the MiniMed Insulin Pumps, Medtronic has faced multiple lawsuits for injuries caused by the devices. Most of these lawsuits have been resolved or settled in the past but the company may be facing new cases.
People injured by the MiniMed 630G or 670G Insulin Pumps due to the failure of the retaining ring, may be considering filing a lawsuit to seek compensation for their injuries and should seek legal assistance.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.