FDA to Investigate Safety and Defective Insulin Pump Reports

The Food and Drug Administration plans to gather experts for its investigation concerning the rising amount of safety issues found with insulin pumps.  Those who work in the industry note past problems have been rooted in both software and hardware components responsible for providing the correct amount of insulin to diabetic patients.  Defective insulin pumps can lead to patients receiving too much or not enough insulin which can lead to serious complications or death.


According to Wall St. Journal, "The FDA said the number of Type I diabetics using insulin pumps has increased, with about 375,000 U.S. users in 2007, up from about 130,000 in 2002."  The FDA also said in it's statement that manufacturers are required to notify the FDA of any potential problems with medical devices.  An FDA review found that insulin pump-related adverse-event reports accounted for up to 17,000 reports between October 2006 and September 2009.  Of those reports, nearly 12,000 confirmed patient injury while another 310 reports resulted in death.