According to allegations raised in a recently filed product liability lawsuit, a South Carolina woman went into a diabetic coma, suffered seizures and other injuries after a recently recalled Medtronic MiniMed infusion pump failed, and dumped its entire insulin reservoir into her body.

The complaint (PDF) was filed by Mara Schwartz in the U.S. District Court for the District of South Carolina on February 21, indicating that Medtronic and Becton Dickinson and Company sold an unreasonably dangerous and defective insulin pump, which has since been the subject of a massive recall.

Schwartz is a registered nurse and a Type 1 Diabetic, who indicates that she used a Medtronic MiniMed Model 630G insulin pump to help regulate her blood sugar. On February 24, 2017, she refilled the device’s insulin reservoir, according to the instructions provided by the manufacturer. However, during the night the insulin pump malfunctioned and injected her with the entire reservoir, causing her to become hypoglycemic due to an insulin overdose.

The lawsuit indicates she was driven into a diabetic coma and when she awakened, discovered her vision was impaired, her movement uncoordinated and she had bruising and injuries indicative of having undergone diabetic seizures. She was later also diagnosed with rhabdomyolysis, orthopedic injuries, neurological damage and post-traumatic stress disorder, which resulted from the Medtronic MiniMed insulin pump failure.

Schwartz later discovered that the infusion set she had used with the device had been recalled in December 2016. The set was recalled again in September 2017, several months after Schwartz’s injuries occurred. Two years later, in November 2019, a Medtronic MiniMed pump recall was issued for the actual device, after thousands of similar reports involving problems

Medtronic sent to customers in November 2019, after discovering that certain pumps may have a missing or broken retainer ring, which could result in the over or under delivery of insulin. The FDA later declared the Medtronic letter to be a Class I medical device recall, which is the most serious recall classification, and indicates that problems with a device could result in serious injury or death.

“The Plaintiff is now informed and believes that her pump likewise malfunctioned due to this defect resulting in the over-delivery of insulin,” the lawsuit states. “It was not until after her injury and the recent recall for all lots, that Plaintiff was ever made aware that this product was unreasonably dangerous and had contributed to her injury.”

The Medtronic MiniMed insulin pumps are small, computerized devices that deliver insulin to diabetic patients throughout the day, via a catheter implanted under the skin. They are wirelessly connected to both the patient’s blood glucose meter and a monitoring system to track glucose levels, as well as a remote controller that is designed to communicate with the pump and deliver a specific amount of insulin.

The FDA announced the Medtronic MiniMed 600 series insulin pump recall on February 12, which impacted more than 300,000 insulin pumps distributed since September 2016. To date, Medtronic has become aware of at least 26,421 complaints in which the insulin pump over or under delivered the programmed amount of insulin, resulting in 2,175 injuries and at least one death.

Medtronic MiniMed Problems

Medtronic has had a number of problems with its Minimed infusion products over the years.

In September 2017, the FDA announced the Medtronic MiniMed infusion pump recall following reports of consumers suffering from hypoglycemia caused by over delivery of insulin. The issue was related to a component of the device called a vent membrane, which can be blocked by fluid. Medtronic discontinued the use of the vent membrane component in April 2017.

In September 2014, Medtronic issued a MiniMed Paradigm insulin pump recall for more than half a million units following reports that programming errors led to patients receiving the wrong dose of insulin. At least one report of hypoglycemia was linked to the problem, which caused some users to accidentally give themselves the maximum insulin dose.

In June 2013, the company issued a MiniMed Paradigm infusion set recall because fluid could get into vents, preventing the pump from priming properly, which could cause severe or even fatal health problems for diabetics. It was one of four recalls or urgent device notifications involving Medtronic’s insulin pumps that year alone.

In 2009, Medtronic Inc. issued a similar recall for approximately three million Quick-set infusion sets used with its MiniMed Paradigm insulin pumps, due to a manufacturing defect that could result in the delivery of incorrect doses of insulin and cause injury or death for diabetics.

Following that recall, a number of Medtronic infusion set lawsuits were filed on behalf of patients of suffered serious injury or death when they received too much or too little insulin.

Schwartz presents claims of strict product liability, negligence, and breach of warranty. She seeking both compensatory and punitive damages.

The lawsuit is the first of what is expected to be hundreds, and potentially thousands, of claims that may be filed by Medtronic MiniMed pump recall lawyers over the coming weeks and months, as individuals realize that insulin pump failures in recent years may have been caused by known defects associated with the device.

Tags: Diabetes, Diabetes Drug, Drug Overdose, Infusion Set, Insulin, Medical Device Recall, Medtronic, MiniMed Pump