FDA Adverse Event Malfunction Summary report: N

DEXCOM G7

MDR report key: 20048131 · Received August 22, 2024

Report

Report Number
MW5158761
Event Type
Malfunction
Date Received
August 22, 2024
Date of Event
August 20, 2024
Report Date
August 20, 2024
Manufacturer
DEXCOM, INC.
Product Code
QBJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IN, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

JUST NOW AWAKENED BY AN INSULIN PUMP ALERT BY A DEXCOM G7 SENSOR TELLING MY PUMP MY BLOOD GLUCOSE WAS CRITICALLY LOW AT 40 WHEN MY BLOOD GLUCOSE ACCORDING TO MY GLUCOMETER WAS 174. I DID CHECK IT TWICE WITH A GLUCOMETER AND TWO DIFFERENT FINGERS. JUST GOT OFF THE PHONE WITH THE DEXCOM CORPORATION TECHNICAL SUPPORT WHO SEEM TOTALLY UNIMPRESSED. I ASKED THEM DID I NEED TO SAVE THE SENSOR TO SEND BACK TO THEM ALL THEY CARED ABOUT WAS REPLACEMENT ONLY. WE HAVE COME A VERY LONG WAY FROM COMPANIES, BEING RESPONSIVE AND ASKING FOR EQUIPMENT THAT'S DEFECTIVE BACK. THIS EQUIPMENT NOT ONLY HAS BEEN DEFECTIVE IN THIS PARTICULAR CASE BUT THE G7 SENSOR CAUSES UNUSUAL BATTERY WEAR ON MY INSULIN PUMP BECAUSE IT'S CONSTANTLY COMMUNICATING WITH THE SENSOR ALL NIGHT, LONG BECAUSE THE SENSOR LIES ON THE SUPINE POSITION OF THE PATIENT WHILE THE INSULIN PUMP IS LOCATED ON THE ANTERIOR SURFACE!!! THE DRAIN ON THE BATTERY IN MY OPINION IS BECAUSE IT'S ON A HUGE BLOCK OF THE BODY ITSELF! THE TINY BATTERY THAT THEY STILL WITHIN THE DEVICE IS NOT ENOUGH POWER OR THE ANTENNA DOES NOT ALLOW FOR THE DEVICE TO FORCE THE INFORMATION TO THE PROPER AREA MY OPINION ONLY MY G6 NEVER DID THIS TO MY INSULIN PUMP!!!! I WOULD SAY THERE'S A MARKED DECREASE OF BATTERY USAGE BY AT LEAST 50% LESS TIME BETWEEN THE G6 SENSOR AND THE G7!! YOUR HUMAN GUINEA PIGS ARE STARTING TO COMPLAIN ABOUT YOUR G7. IT'S OK TO USE.! I WILL KEEP FOR THE NEXT TWO WEEKS THIS DEFECTIVE SENSOR THAT I HAVE TO REPLACE PLUS THE BOX AND ORIGINAL PACKAGING!!! SINCE DEXCOM COULD CARE LESS ABOUT A RETURN. I WAS WONDERING IF THE FDA WOULD LIKE TO LOOK AT THIS DEFECTIVE EQUIPMENT OR NOT? I CAN BE CONTACTED AT (B)(6). THANK YOU. SENSOR USING INSULIN PUMP PATIENT SINCE FDA CLEARED ITS USAGE. WITH BOTH MEDTRONIC SENSORS THREE DIFFERENT TYPES, AND DEXCOM G6-7. "250731; 240201". REFERENCE REPORT: MW5158762.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
231899 DEXCOM G7 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC. 1724052002

Patients

Seq Age Sex Outcome Treatment
1 64 YR Male Other "LOT-CON M20 2 X WEEKLY".| COPPER 18 MG.| COQ 10.| HEMP OIL 1.3 GRAMS.| INSULIN PUMP.| LIPITOR 80MG.| LIPITOR.| MAGNESIUM 500MG.| METFORMIN 1000MG.| OMEPRAZOLE 40MG.| THIAMIN 1 500 MG.| VITAMIN B1. | VITAMIN B12.| VITAMIN D2.| ZINC 50 MG.