The newswires have reported that the Food and Drug Administration (FDA) notes "problems with insulin pump devices". To provide members with more information, the Drug and Therapeutics Committee has reviewed the FDA report. The report was released to the public because the FDA is holding a device panel meeting notice on March 5, 2010 to review reported post-market adverse events and recalls. Of the approximately 16,000 adverse events reported from 2005-2009, 19% were reported as 'unknown device problem' and 9% were reported as 'replace device'. The adverse events experienced included DKA, hyper or hypoglycemia, 'blood glucose', and hospitalization. Of the 310 deaths reported (ranging from motor vehicle accident to 'diabetic coma' to unresponsiveness), the received information was incomplete and the pump was not evaluated, so whether pump malfunction was the underlying cause of the death was unclear in the vast majority of cases. 'Infusion set problems' were implicated in four deaths all presumably involving hypoglycemia but again the pump was not evaluated. The 18 pump recalls since 2004 affected about 4.5 million distributed pumps. The largest recall, of 3.8 million pumps was for a venting defect in the medication cartridge that affects insulin infusion. Other recalls were for software glitches and battery problems, among others. The panel contains pediatric and adult endocrinologists, FDA officials, manufacturer representatives, and consumer representatives. The goal of the meeting is to discuss strategies to improve adverse event reporting in order to provide meaningful information as to root cause of the adverse event and to discuss the risks of continued patient use of a functioning recalled (therefore defective) device vs. changing mode of insulin administration. No comment was made in the report as to when the panel would release their conclusions. More information is available at http://www.fda.gov/AdvisoryCommittees/ |