Medtronic MiniMed Lawsuit Filed Over Paradigm Insulin Pump Problems

A product liability lawsuit filed by a New York man alleges that a Medtronic MiniMed Paradigm insulin pump caused him to suffer severe hypoglycemia due to a pump malfunction. 

The complaint (PDF) was filed by William F. Mills in the U.S. District Court for the Southern District of New York on June 26, alleging that the Medtronic MiniMed pump was defectively designed, resulting in a failure to deliver the appropriate amounts of insulin to control his diabetes.

Mills indicates that he began using the MiniMed Paradigm insulin pump in 2010, in an effort to manage and control his type 2 diabetes. In June 2012, the complaint indicates that he lost consciousness in his bathroom, falling and injuring his face and hip. He was diagnosed with hypoglycemia, or low blood sugar, which the lawsuit claims was due to the malfunctioning insulin pump.

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Medtronic MiniMed Lawsuits

Recalled Medtronic MiniMed insulin pumps have been linked to reports of hypoglycemia, hyperglycemia and other serious injuries.

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According to allegations raised in the Medtronic MiniMed pump lawsuit, there have been known issues with the device for years, but the manufacturer failed to take appropriate actions to prevent consumers from suffering serious injuries.

In 2009, the FDA accused the company of dragging its feet on addressing customer complaints in a warning letter that revealed that the company waited 18 months before reporting a MiniMed Paradigm Insulin Pump device malfunction. The company is required to report the incident within 30 days.

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

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 using the Medtronic insulin pumps.

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.

Mills accuses Medtronic of failure to warn, designing and manufacturing a defective product, negligence, and breach of warranty, seeking both punitive and compensatory damages.

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2 Comments

  • PatsyFebruary 6, 2017 at 4:44 am

    On 2/2/2017 I had to be taken by ambulance to the hospital for hypoglycemia. There have been several weeks of problems with overdosing of insulin. I have since went through steps with Medtronic to determine if the pump was working properly. They confirmed it was. However, I had recently started using a new supply of reservoirs and quick-sets. Since the use of the new box of supplies the deliv[Show More]On 2/2/2017 I had to be taken by ambulance to the hospital for hypoglycemia. There have been several weeks of problems with overdosing of insulin. I have since went through steps with Medtronic to determine if the pump was working properly. They confirmed it was. However, I had recently started using a new supply of reservoirs and quick-sets. Since the use of the new box of supplies the delivery of insulin has caused multiple hypoglycemia results. I need to know what can be done! Medtronic has sent replacements for the one box of supplies I was using and said to start another box and to send the remainder of the unused box back to them.

  • EdmondJuly 7, 2016 at 1:26 am

    I have had a near death experience with this same pump, in May 2016 my pump just quit with no warning! My blood sugar wit from a normal of 130 to over 1285! I became unconscious and had to be taken to the hospital by ambulance. where I remained for almost a week in ICU, Hospital Doctors, Nurses, Paramedics and Diabetes Center people all examined this pump and said it just failed! Medtronic said so[Show More]I have had a near death experience with this same pump, in May 2016 my pump just quit with no warning! My blood sugar wit from a normal of 130 to over 1285! I became unconscious and had to be taken to the hospital by ambulance. where I remained for almost a week in ICU, Hospital Doctors, Nurses, Paramedics and Diabetes Center people all examined this pump and said it just failed! Medtronic said sorry!

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