DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2025-220207
- Event Type
- Malfunction
- Date Received
- August 12, 2025
- Date of Event
- July 15, 2025
- Report Date
- September 10, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270002525
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). 3004753838-2025-220207 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4).
(B)(4). 3004753838-2025-220207 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 8/13/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. 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 8/13/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62869 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 17276923 | 00386270002525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | INSULIN DEVICE UNKNOWN |