MAUDE MDR 4284323

MDR report key
4284323
Report number
MW5039294
Event key
0
Event type
3
Date of event
2014-11-22
Date received
2014-11-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEXCOM 4G TRANSMITTERTRANSMITTERDEXCOMDXH
2DEXCOM 4G RECEIVERRECEIVERDEXCOMDXH

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-2201. L; 2. R; 3. S

Event Narratives#

D

Patient 1

IN (B)(6), I REPORTED TO DEXCOM THAT I HAD A PROBLEM WITH MY DEXCOM TRANSMITTER AND RECEIVER. I AM DIABETIC. MY BLOOD SUGAR WAS EXTREMELY LOW AND I HAD TROUBLE WALKING. THE DEXCOM DID NOT ALARM AS IT SHOULD HAVE. I HAD TO TREAT MY LOW BLOOD SUGAR. ABOUT 1/2 HOUR LATER, IT FINALLY ALERTED ME THAT I HAD LOW BLOOD SUGAR, BUT I HAD ALREADY TREATED IT. I ALSO TOLD THEM THAT MY ALERT SIGNALS THAT THE DEXCOM COULD PLAY WOULD ONLY VIBRATE. I TRIED EVERY LOUD SOUNDING OPTION, BUT IT WOULD ONLY VIBRATE. I CALLED DEXCOM AND THEY SAID THEY WERE GOING TO REPORT THIS TO THE FDA. I AM NOT SURE IF YOU RECEIVED THIS COMPLAINT FROM THEM. THEY TOLD ME THAT I NEEDED A NEW TRANSMITTER/RECEIVER. HOWEVER, AFTER LOOKING UP MY INFORMATION, THEY TOLD ME THAT I HAD TO GO THROUGH THE (B)(6). SO I CALLED THE (B)(6). THEY TOLD ME THAT WAS NOT TRUE. THEY SAID DEXCOM SHOULD REPLACE IT. THEY PUT ME ON HOLD FOR 1/2 HOUR, BUT I HAD TO GO BACK TO WORK. I AM NOT SURE WHY THEY COULD NOT WORK THIS OUT WITHOUT ME. DEXCOM AND (B)(6) SHOULD HAVE DECIDED WHO WOULD BE SENDING ME A NEW TRANSMITTER/RECEIVER. THIS PAST (B)(6), I GOT EXTREMELY LOW AT 3 AM. I DID NOT HEAR IT BECAUSE IT ONLY VIBRATED. MY FRIEND WAS WITH ME AND IDD NOT HEAR IT EITHER. I TRIED TO GET UP AND FELL AND HIT MY HEAD. AT 7:15 AM, MY FRIEND NOTICED THAT I WAS NOT WAKING UP AND THERE WAS SOMETHING WRONG. HE POURED 3 PACKS OF SUGAR UNDER MY TONGUE. I FINALLY STARTED COMING AROUND AND MY BLOOD SUGAR WAS 29. THIS MEANS I WAS LESS THAN THIS FOR OVER 4 HOURS AND I WAS NOT ALERTED BECAUSE OF A MALFUNCTIONING DEXCOM THAT SHOULD HAVE BEEN REPLACED. I COULD HAVE DIED WITHOUT MY FRIEND FINDING ME LIKE THIS. I ALSO HAVE A BLACK EYE FROM FALLING WHEN I TRIED TO GET UP.