FDA Adverse Event Malfunction Summary report: N

DEXCOM CGM

MDR report key: 7040889 · Received November 16, 2017

Report

Report Number
MW5073392
Event Type
Malfunction
Date Received
November 16, 2017
Date of Event
November 14, 2017
Report Date
November 15, 2017
Manufacturer
DEXCOM
Product Code
MDS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I AM A LONG STANDING TYPE 1 DIABETIC AND MY ENDOCRINOLOGIST HAD BEEN ENCOURAGING ME TO USE A CGM DEVICE. I TRIED THE DEXCOM G5 FOR ABOUT 6 MONTHS BUT I HAD CONTINUOUS IT ISSUES AND THE TRANSMITTERS WOULD NOT IDENTIFY MY (B)(6) AND EVENTUALLY I JUST GAVE UP. RECENTLY DUE TO A NUMBER OF HYPOGLYCEMIC EPISODES. I DECIDED TO TRY THE DEVICE AGAIN. I REQUESTED A NEW TRANSMITTER WHICH DEXCOM SENT TO ME (AND BILLED MY INSURANCE) BUT THE SAME IT ISSUES PERSIST AND I CANNOT CONNECT THE TRANSMITTER (INSERTED INTO ABDOMEN) TO MY (B)(6). I CALLED DEXCOM IT YESTERDAY AND THE REP INFORMED ME THAT THERE IS A KNOWN BUG IN THE SYSTEM AND I CANNOT USE THE G5 TRANSMITTER WITH THE CURRENT DOS SYSTEM ON MY (B)(6). DEXCOM IS AWARE OF THE MATTER AND THEIR ENGINEERS ARE WORKING ON A SOLUTION. THIS IS FINE, HOWEVER, IT IS EXTREMELY FRUSTRATING TO KNOW THAT A MEDICAL DEVICE COMPANY CAN CONTINUE TO PROVIDE AND BILL INSURANCE FOR A PRODUCT WHEN THAT (B)(6) USERS (AND I SUSPECT THERE ARE MANY) WILL NOT BE ABLE TO CONNECT. THIS IS FRAUDULENT IN MY OPINION AND I WANT TO ADVISE MY PRESCRIPTION PROVIDER TO NOT PAY FOR THIS PRODUCT; HOWEVER, I AM CONCERNED THAT THEY WILL DENY FUTURE REQUESTS ONCE DEXCOM CAN CORRECT THE ISSUES. FURTHERMORE, I HAVE SPENT COUNTLESS HOURS TRYING TO GET THIS RESOLVED AND NUMEROUS ATTEMPTS AT RE-INSERTING THIS MEDICAL DEVICE INTO MY ABDOMEN WITH NO CLINICAL BENEFIT. THIS IS VERY FRUSTRATING AND AN INEFFICIENT USE OF HEALTHCARE DOLLARS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
815576 DEXCOM CGM DEXCOM CGM MDS DEXCOM

Patients

Seq Age Sex Outcome Treatment
1