We have written about issues surrounding <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">insulin pump malfunctions and recalls in recent years. Now, Reuters reports that the U.S. Food & Drug Administration (FDA) is working to reduce risks from dangerous problems that affect what it described as tens of thousands of diabetics. While the FDA did not provide specific insulin pump manufacturers names in its report, it is largely known that insulin pump makers include Medtronic Inc, Roche Holding AG, and Johnson & Johnson, said Reuters.
The issue with defective insulin pumps is that the devices, when not operating properly, can result in either high or low blood sugar when appropriate insulin amounts are not delivered, which can result in very dangerous outcomes, including death, explained Reuters. “Device problems critical to insulin pumps exist across manufacturers,” FDA staff said in a report it prepared for an advisory panel that meets tomorrow.
Insulin pumps are typically worn by type 1 diabetics who require daily insulin injections to maintain blood sugar control and are used by both pediatric and adult patients, said Reuters, noting that insulin pumps offer patients the convenience of not having to inject several times daily. According to the agency, some 375,000 type 1 diabetic adults used insulin pumps in 2007; in 2002, the figure was 130,000, reported Reuters.
A variety of recalls have been initiated over recent years for an array of problems that have potentially placed diabetics in danger. According to the FDA, there is also “an increasing trend in software and hardware device problems across manufacturers,” quoted Reuters.
Last year, Medtronic Inc. recalled some of its Quick-set insulin infusion sets used with MiniMed Paradigm insulin pumps because of a potential defect in how air pressure vented, causing delivery of improper amounts of insulin and the potential for serious injury or death. Medtronic also received a warning letter regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump. The FDA cited Medtronic for taking too long to recall the SynchroMed pumps and said an inspection conducted the prior year at the Puerto Rican plant where both pumps were made found Medtronic failed to establish and maintain manufacturing quality controls. According the letter, some SynchroMed pumps were released for distribution and implanted in patients even though they were not filled with a needed propellant. The pumps were recalled for this problem in May 2008, after Medtronic received two reports of SynchroMed pumps being removed from patients because of a lack of propellant.
Accu-Check Spirit insulin pumps were previously recalled by Disetronic Medical Systems Inc., a unit of the Roche Group, because of a potential defect in the â€œupâ€ and/or â€œdownâ€ buttons of some devices. Malfunctioning buttons could prohibit users from changing any programmed setting on the Accu-Check Spirit insulin pumps. Another earlier recall was issued for battery caps included with some varieties of Aimas insulin pumps. According to Animas Corp, the defective battery caps could cause the pumps to stop administering insulin, putting patients at risk of hyperglycemia or hypoglycemia.
The FDA said it is seeking recommendations from an external panel of experts on how to improve reporting, problem investigation, and recall processes, said Reuters. The agency looked at close to 17,000 reports of insulin pump-related health problems from 2006 through 2009 and also reviewed 310 fatality reports, said Reuters. Of these, in 225 “the device problem was unknown and limited details of the event were provided,” said FDA staff. In 41, patients suffered from â€œdiabetic coma, low blood sugar, or other problemsâ€ before death, said Reuters. The device-adverse reaction link requires further research based on missing reporting data.