FDA Adverse Event Injury Summary report: N

DEXCOM G6

MDR report key: 8310481 · Received February 5, 2019

Report

Report Number
MW5083712
Event Type
Injury
Date Received
February 5, 2019
Date of Event
February 4, 2019
Report Date
February 4, 2019
Manufacturer
DEXCOM
Product Code
QBJ
UDI-DI
00386270000255
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
KY, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

THE DEXCOM G6 HAS BEEN MALFUNCTIONING FOR MY DAUGHTER SINCE (B)(6) 2018 WHEN SHE GOT IT. IT IS ALWAYS 150, 100, TO 50 POINTS OFF. I HAVE REPORTED THIS NUMEROUS TIMES TO DEXCOM. IT IS THE SAME EXCUSE THEY ARE WORKING TO FIX IT FOR SIX MONTHS. TODAY WAS EVEN MORE DANGEROUS AS MY CHILD DROPPED WHILE SHE WAS ON THE SCHOOL BUS, THE DEXCOM READ SHE WAS 84 SHE DID A FINGERSTICK AND WAS 24. ONCE MY DAUGHTER TEXT ME THIS INFORMATION SHE CHECKED THE DEXCOM AND I CHECKED MINE ON MY PHONE AND IT SAID SHE WAS 72 AND HER BLOOD SUGAR WAS 24. THIS DEVICE DOES NOT WORK LIKE IT SHOULD, IT IS SUPPOSED TO BE BETTER THAN BEFORE ALL THESE PROMISES THAT DEXCOM PROVIDED, ONLY PROVEN FALSE. THREE TIMES IN SIX MONTHS IT¿S ONLY BEEN ACCURATE AND THAT IS A PROBLEM. WE RELY ON FINGERSTICKS MORE THAN THE DEXCOM. IT IS UNABLE TO KEEP UP WHEN SHE DROPS, IT¿S UNABLE TO KEEP UP WHEN SHE¿S HIGH. WHY IS THIS DEVICE WAS EVEN APPROVED YET DEXCOM IS AWARE OF ALL OF THESE ISSUES IS BEYOND ME. TODAY I HAD TO CALL THE COMPOUND AND HAVE THEM RADIO HER BUS DRIVER, HER BUS DRIVER WAS KIND ENOUGH TO MAKE AN EMERGENCY DETOUR AND NOT DROP OFF HER KIDS TO GET MY DAUGHTER HOME TO ME QUICKLY. WHILE MY DAUGHTER SAT THERE WITH HER GLUCAGON IN HER HAND CRYING AND WHEN SHE GOT OFF THE BUS IN TEARS AND TERRIFIED. THIS MACHINE NEEDS TO BE PULLED FROM THE MARKET UNTIL THEY ACTUALLY FIX IT. I AM CONSIDERING CONSULTING AN ATTORNEY ON THIS BECAUSE THIS IS A FAULTY BASICALLY PIECE OF JUNK THAT¿S OVERPRICED, AS WELL EXTREMELY DANGEROUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
101737 DEXCOM G6 INTEGRATED CONTINUOUS GLUCOSE MONITORNG SYSTEM QBJ DEXCOM 5243695 00386270000255

Patients

Seq Age Sex Outcome Treatment
1 11 YR Life Threatening| O