FDA EIR - Dexcom, Inc. - March 29, 2016

An FDA Post-Market Surveillance inspection of Dexcom Inc., a manufacturer of continuous blood glucose monitoring systems in San Diego, CA, was conducted from March 22-29, 2016. The inspection, carried out under Compliance Program Guidance Manual 7383.001, focused on post-market activities for medical devices, specifically Dexcom's G4 Platinum systems and components supplied for the Animas Vibe System. It encompassed a review of the company's Quality System Inspection Technique (QSIT) subsystems, including Management Review, Corrective and Preventive Actions (CAPA), Design Controls, and Production and Process Controls. The primary observation noted on an FDA Form 483 was the company’s failure to fully implement written Medical Device Reporting (MDR) procedures. While Dexcom Inc. updated its MDR Reporting procedure in November 2015 to classify a specific 'failed error' complaint code as a reportable malfunction, the firm did not perform a comprehensive retrospective review of approximately 565 prior complaints received with this now-reportable code between November 2014 and June 2015. Despite claims that none of these complaints resulted in serious injury, the revised procedure mandated reporting of all such malfunctions. Consequently, Dexcom Inc. is required to rectify this deficiency, ensuring their MDR procedures are rigorously followed, including conducting retrospective analyses of complaints when reporting classifications are updated, to comply with regulatory obligations.