FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 21698276
·
Received March 26, 2025
Report
- Report Number
- 3004753838-2025-070966
- Event Type
- Malfunction
- Date Received
- March 26, 2025
- Date of Event
- February 28, 2025
- Report Date
- August 14, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
(B)(4). 3004753838-2025-070966 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. 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 3/21/2025, AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1804800 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1824335003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female |