DexCom Warning Letter Points to MDR Problems

DexCom, a San Diego maker of continuous glucose monitors, has been warned over medical device reporting failures and problems with its MDR procedure. For four complaints of hypoglycemia while using the device, the company did not submit an MDR, even though medical interventions for hypoglycemia were considered necessary to prevent permanent impairment or damage, according to the March 14 letter posted online recently.
The GMP Letter