This week, the Food and Drug Administration (FDA) and the medical device maker Dexcom both released the text of a warning letter the FDA sent Dexcom earlier this month over incidents involving the Dexcom G4 Platinum Continuous Glucose Monitoring System used by people with diabetes. At issue was the company’s failure to report at least four incidents of low blood sugar requiring medical attention and at least one instance in which the device shocked a patient.
When Dexcom disclosed the letter, the company said only that the letter flagged “deficiencies in filing medical device reports (MDRs) involving the company’s continuous glucose monitoring system,” MassDevice.com reports. The letter indicates that Dexcom, based in San Diego, did not submit the required MDRs for four incidents “where patients sustained an injury (i.e. hypoglycemia) while using your firm’s device.” MDRs were required, the FDA explains, because the incidents are “considered medical interventions necessary to preclude permanent impairment or a body function or permanent damage to a body structure.” In addition, the letter refers to a report that “reasonably suggests” that the device “malfunctioned” and shocked a patient.
Alonza E. Cruse, director of the FDA’s Los Angeles district, writes that the FDA inspected Dexcom’s facility from October 30 through November 7, 2013, but cannot determine whether Dexcom’s November 26 response to the problems found during the inspection is adequate. “The response indicates that actions will be completed in the future to include a revised MDR procedure and retrospective review of complaints and submission of MDRs to FDA.” Evidence of completion of the proposed actions was not included in Dexcom’s response. “Without this documentation in hand we cannot determine the adequacy of your firm’s response,” Cruse writes.
Dexcom has 15 business days from receipt of the letter to respond, informing the FDA how it has corrected the violations and how it will prevent similar violations in the future. The company said it plans to be in compliance with FDA rules by the end of April, MassDevice reports.