FDA WARNING_LETTER - Dexcom, Inc. - February 08, 2010

On May 21, 2010, the FDA issued a Warning Letter to DexCom, Inc. following an inspection from January 11 to February 8, 2010. The inspection revealed that DexCom's Seven PLUS Continuous Glucose Monitoring System (Class III) was misbranded under 21 U.S.C. 352(t)(2) due to failures in Medical Device Reporting (MDR) as required by 21 C.F.R. Part 803.

The primary violation was the failure to submit MDR reports within 30 days for device malfunctions likely to cause or contribute to death or serious injury if recurred (21 CFR 803.50(a)(2)). Specifically, DexCom failed to report multiple instances of sensor wire fractures retained under patients' skin, some requiring surgical removal, including cases involving young children. The FDA cited six specific customer reports (09-5141, 09-0274, 09-3516, 09-3641, 09-5555, 09-4237) detailing these incidents.

DexCom's March 2, 2010, response was deemed inadequate. While the firm agreed to submit MDRs for sensor wire fractures received after January 1, 2008, and