FDA Adverse Event Malfunction Summary report: N

DEXCOM G7 RECEIVER

MDR report key: 22588199 · Received July 24, 2025

Report

Report Number
MW5173228
Event Type
Malfunction
Date Received
July 24, 2025
Report Date
July 21, 2025
Manufacturer
DEXCOM, INC.
Product Code
QBJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

RECEIVED URGENT: MEDICAL DEVICE CORRECTION UPDATE FROM DEXCOM FOR MY DEXCOM G7 RECEIVER, (B)(6). I VERIFIED THAT MY RECEIVER WAS AFFECTED AND HAVE BEEN ATTEMPTING TO CONTACT DEXCOM TECHNICAL SUPPORT AT 1-844-478-1600 DAILY FOR THE PAST EIGHT DAYS TO COORDINATE RETURN OF THE AFFECTED RECEIVER AND RECEIPT OF A REPLACEMENT. EACH OF THE NUMEROUS CALLS I HAVE MADE HAVE GONE UNANSWERED AND REQUESTS FOR A CALLBACK TO AVOID FURTHER WAITING HAVE NEVER BEEN RETURNED. CALLS TO OTHER DEXCOM SUPPORT NUMBERS REFER ME BACK TO THE ABOVE NUMBER THAT GOES UNANSWERED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1088588 DEXCOM G7 RECEIVER INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC. MT26403-0

Patients

Seq Age Sex Outcome Treatment
1 NA Male ADVAIR HFA| AZELASTINE| CARVEDILOL | DILTIAZEM| DOXAZOSIN MESYLAT| FLUTICASONE | IBUPROFEN | LANTUS INSULIN| METFORMIN | MOUNJARO| MULTI-VITAMIN| NOVOLOG INSULIN| PREVASTATIN | VALSARTAN/HYDROCHLOROTHIAZIDE| VITAMIN D2