Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013, TO REPORT THAT ON (B)(6) 2013, AT APPROXIMATELY 2:30AM, SHE HAD EXPERIENCED A HYPOGLYCEMIC EVENT. WHILE STANDING IN THE RESTROOM, SHE BECAME DISORIENTED AND FELL. DURING THE FALL, SHE HIT AND CUT HER HEAD. PATIENT CALLED HER NEIGHBOR WHO THEN CALLED THE PARAMEDICS. UPON ARRIVAL, THE PARAMEDICS MEASURED PATIENT'S BG AT 22 MG/DL AND ADMINISTERED GLUCOSE IV. PATIENT WAS TAKEN TO THE HOSPITAL WHERE SHE WAS TREATED FOR HYPOTHERMIA, AND RECEIVED STITCHES FOR HER HEAD LACERATION. THE PATIENT BELIEVES THAT THE HYPOGLYCEMIC EVENT BEGAN A FEW HOURS PRIOR TO THE FALL, ON THE EVENING OF (B)(6) 2013. SHE CLAIMS THAT HER CGM RECEIVER DID NOT ALERT HER OF THE HYPOGLYCEMIC EVENT. PATIENT DOES NOT RECALL DETAILS ABOUT THE INCIDENT, NOR THE CGM VALUE AT THE TIME OF INCIDENT. DEXCOM REQUESTED THE RECEIVER BE RETURNED TO DEXCOM FOR INVESTIGATION. NO PRODUCT HAD BEEN RECEIVED BY DEXCOM AT THE TIME OF THIS REPORT. AT THE TIME OF HER INITIAL CALL TO TECHNICAL SUPPORT, PATIENT REPORTED BEING SORE AND BRUISED AT SITE OF FALL IMPACT. SHE REPORTED BEING WEAK BUT RECOVERING. DURING A FOLLOW-UP CALL BETWEEN DEXCOM TECHNICAL SUPPORT AND PATIENT ON (B)(6) 2013, REPORTED THAT SHE WAS HEALING WELL AND WAS IN FINE CONDITION.