FDA WARNING_LETTER - Dexcom, Inc. - November 07, 2013

On March 14, 2014, the FDA issued a Warning Letter to Dexcom, Inc. following an inspection from October 30 to November 7, 2013. The inspection revealed that Dexcom's G4 Platinum continuous glucose monitor was misbranded under section 502(t)(2) of the Act due to failures in Medical Device Reporting (MDR) as required by 21 CFR Part 803.

Significant deviations included: 1. Failure to report to the FDA within 30 calendar days information suggesting the device caused or contributed to a death or serious injury (21 CFR 803.50(a)(1)). Examples cited were complaints #3773278, #3744878, #3850840, #3812058, where patients experienced hypoglycemia requiring medical intervention, but no MDRs were submitted. 2. Failure to report to the FDA within 30 calendar days information suggesting a device malfunctioned and would likely cause or contribute to a death or serious injury if it recurred (21 CFR 803.50(a)(2)). Complaint #3672534, involving electrical shocks, was cited as an example where no MDR was submitted. 3. Failure to adequately develop, maintain, and implement written MDR procedures (2