FDA Issues Warning to Dexcom Over its Glucose MonitorsMar 28, 2014
The U.S. Food and Drug Administration (FDA) just issued a warning letter to medical device maker, Dexcom, concerning its blood glucose monitors following an inspection of the device maker’s facility.
According to the agency’s letter, Dexcom neglected to report at least four cases in which low blood sugar levels mandated medical treatment and one case in which Dexcom’s glucose monitor shocked a patient, according to a recent MassDevice.com report.
Dexcom disclosed that it had received the March 14 FDA warning letter this week, indicating that the letter flagged "deficiencies in filing medical device reports (MDRs) involving the company's continuous glucose monitoring system," MassDevie.com reported.
The FDA just published the warning letter, which revealed that Dexcom received four reports of "events where patients sustained an injury (i.e. hypoglycemia) while using your firm’s device. The patients were treated with glucose tablets or glucagon." The FDA indicated that it had inspected Dexcom's facility from October 30 through November 7, the letter also indicated, wrote MassDevice.com.
"The referenced medical interventions to treat hypoglycemia are considered medical interventions necessary to preclude permanent impairment or a body function or permanent damage to a body structure. Your firm did not submit an MDR for each referenced event," the FDA wrote. Also, Dexcom received a report that "reasonably suggests that your firm’s device malfunctioned (i.e. electrical shocks)," the letter also stated.
The FDA also addressed the potential for other malfunctions, serious injuries, and death. "There is no information in your firm’s complaint file to justify why the referenced malfunction would not be likely to cause or contribute to a reportable death or serious injury, if it were to recur. Your firm did not submit an [medical device report] for the referenced event," the FDA also wrote.
The FDA indicated that it is unable to ascertain if Dexcom's response to the problems that were discovered during its investigation is adequate. Dexcom indicated that it intends on being in compliance with FDA rules by the end of April, according to MassDevice.com.
According to the FDA, Dexcom may not have fully addressed the matter, stating in its letter that, "The adequacy of your firm’s response dated November 26, 2013, cannot be determined at this time. 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. No evidence of completion for the proposed actions were included in your firm’s response. Without this documentation in hand we cannot determine the adequacy of your firm’s response."
The FDA advised Dexcom that it must take prompt action to correct the violations addressed in the letter and that it must advise the regulator within 15 business days of receiving the letter with detailed steps it has taken to correct the outlined violations, among other mandates.