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 |