FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 22727991
·
Received August 6, 2025
Report
- Report Number
- 3004753838-2025-212317
- Event Type
- Malfunction
- Date Received
- August 6, 2025
- Date of Event
- July 11, 2025
- Report Date
- August 20, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270001788
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
(B)(4). 3004753838-2025-212317 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE. G3: DATE RECEIVED BY MFG ¿ ADDITIONAL INFORMATION
Description of Event or Problem · 0
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. IT WAS INDICATED THE PATIENT STARTED THEIR TRANSMITTER PAST THE 'USE BY' DATE, WHICH IS MISUSE OF THE DEVICE. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Description of Event or Problem · 0
AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 7/24/2025 IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1569357 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | P16450144 | 00386270001788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Female | OMNIPOD 5 |