DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2025-043543
- Event Type
- Malfunction
- Date Received
- February 21, 2025
- Date of Event
- February 6, 2025
- Report Date
- July 30, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- K213919
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). 3004753838-2025-043543 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4).
(B)(4). 3004753838-2025-043543 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 2/24/2025. IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
IT WAS REPORTED THAT A DETACHED NEEDLE OR CANNULA OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 2/24/2025. IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1636722 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1724355001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female |