DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2025-201656
- Event Type
- Malfunction
- Date Received
- July 29, 2025
- Date of Event
- July 7, 2025
- Report Date
- September 13, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270003935
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). 3004753838-2025-201656 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4).
(B)(4). 3004753838-2025-201656 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 7/18/2025, AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED 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.
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 7/18/2025, AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1788262 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1825067009 | 00386270003935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female |