FDA Warning to Dexcom G4 Platinum Continuous Glucose Monitoring System

Following an inspection of the San Diego company Dexcom, Inc., on March 14 the FDA issued a warning letter to the company  regarding alleged misbranding violations under the FDA's Medication Device Reporting (MDR) Regulation.  The FDA cited the firm's failure to provide FDA with required information regarding reported injuries sustained by patients while using Dexcom's G4 Platinum continuous glucose monitor.  Events that were unreported included cases of patients developing hypoglycemia while using the device and evidence that the device malfunctioned and caused electrical shocks.  The FDA required Dexcom to submit a response to the letter within fifteen business days addressing all violations and stating the time in which corrections will be made.
[1] FDA Warning Letter, Dexcom Inc. ( 3/14/14).