FDA Addresses Increased Insulin Pump Recalls
The U.S. Food and Drug Administration held an advisory panel meeting on insulin pumps earlier this month to “make recommendations regarding clinical risks and benefits of post-market actions in response to insulin pump failures.” Reports from the FDA noted 18 insulin pump recalls on its list of medical product recalls over a period of five years, according to the Wall Street Journal.
A Medtronic insulin pump lawsuit was filed several months ago in November 2009 in U.S. District Court in the Southern District of Texas on behalf of diabetic patients who used the MiniMed pump. They allege they received the wrong insulin dosages and then had to be hospitalized. The plaintiffs say they were using Paradigm Quick-Set infusion sets, which are thin plastic tubes that carry the insulin from the pump to the diabetes patient. These infusion sets were supposed to work with the MiniMed pumps, but were recalled in June 2009. According to the FDA’s announcement:
“These infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may cause serious injury or death.”
However, FDA staff said in reports from the March 5 meeting that “device problems critical to insulin pumps exist across manufacturers.” After the meeting, the panel recommended that insulin pump manufacturers, such as Medtronic, Roche Holding AG, Abbott Laboratories, Hospira Inc. and Johnson & Johnson, include more information when reporting potential insulin pump problems, according to news reports. This could help trace the sources of insulin pump problems, the panel reported.
Tags: Insulin Pump Lawsuit, Medical Device Recall, Medtronic Lawsuit
