A wrongful death lawsuit has been filed against Medtronic by a woman whose daughter allegedly died due to problems with Medtronic Paradigm Quick-Set Infusion sets used with the MiniMed insulin pump.
The complaint (PDF) was filed by Alice Pierce in the U.S. District Court for the District of Minnesota on July 3.
Pierce’s daughter, Carol Givens, died after using a Medtronic infusion set, which is a small disposable plastic tube used to deliver insulin from the pump.
The same month as Given’s death, Medtronic recalled approximately three million Quick Set infusion sets for its MiniMed pumps due to manufacturing defects, which the company acknowledged could result in the delivery of incorrect doses of insulin.
Givens used the Medtornic insulin pump without realizing that it was failing to give her the correct dose. As a result, she was hospitalized for diabetic ketoacidosis after failing to control her glucose levels. She was hospitalized several times that year for blood sugar problems, unaware that the insulin pump infusion sets were defective, the lawsuit claims.
In June 2009, Piece indicates that her daughter fell into a coma and never regained consciousness. Givens died July 9, 2009, of cerebral anoxia from a diabetic hypoglycemic coma.
The very next day after Givens’ death, on July 10, Medtronic issued a MiniMed Paradigm Quick-Set Infusion Set recall for all products that had a lot number beginning with “8,” indicating that they may not vent air pressure properly, resulting in incorrect doses of insulin.
Givens’ infusion set was from Lot 8200921.
Medtronic Infusion Set Recall
Paradigm Quick-Set Infusion Sets have vents incorporated into the tubing connector, which is intended to allow air to pass in and out of the pump’s reservoir compartment. The vents equalize pressure in the reservoir compartment of the insulin pump with the surrounding atmosphere and are necessary to ensure insulin is properly delivered to the patient.
According to the complaint, a lubricant applied during the manufacturing process caused the vents in some of the recalled infusion sets to become clogged. This prevented the Medtronic insulin pump from venting air pressure properly, causing the device to deliver too much or too little insulin.
The recall came weeks after the FDA sent a warning letter in June 2009 to Medtronic over problems with quality control and reporting at a Puerto Rico plant. Following an investigation, the FDA indicated that the company had problems with reporting and investigating device malfunctions that may be “symptomatic of serious problems” in Medtronic’s manufacturing and quality assurance procedures.
In a press release issued in July 2009, Medtronic indicated that approximately 2% of the recalled infusion sets were expected to have the problems venting air pressure properly when delivering an insulin dose, which suggested that about 60,000 of the small plastic tubes distributed were defective.
Pierce’s complaint joins a number of similar Medtronic insulin pump lawsuits filed over problems with the infusion sets since the recall.