Treatment

Man Sues Medtronic for Pump Defect After Wife’s Death

According to The Legal Examiner, a Mississippi man is suing Medtronic following his wife’s death last year. The plaintiff claims that his deceased spouse’s MiniMed insulin pump administered too much insulin while she was sleeping. He is seeking $75,000 in damages.

The plaintiff’s wife was a bank loan officer and the mother of two children. According to the plaintiff, the 56-year old was very healthy at the time of her death. One night in January of 2017, she changed the site of her insulin pump, which holds up to one week’s worth of the drug, and went to bed. The next morning, she was unresponsive.

Paramedics arrived and transported her to the hospital, where doctors found that she had suffered a stroke brought on by a severe low blood sugar. She survived for two months before dying on March 14, 2017.

The plaintiff is claiming that the low blood sugar was caused by a product defect. In November of 2017, the FDA recalled over two million Medtronic MiniMed Sure-T infusion sets, claiming that the devices had the potential to over-administer insulin. This risk was due to defective “vent membranes,” which could become blocked during priming and fill-tubing, leading to the delivery of too much of the drug. Healthcare providers had been warned in advance via a press release (in September) about this problem.

It is not the first incidence of malfunction for Medtronic, which is the biggest insulin pump manufacturer. In 2009, Medtronic was warned by the FDA for failing to properly report and address defects in its MiniMed pump. At the time, the agency also identified numerous manufacturing facilities that were not operating according to established protocols.

Photo Credit: 360b / Shutterstock.com

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Audrey Farley is a former editor of Insulin Nation.

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