DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2025-231143
- Event Type
- Malfunction
- Date Received
- August 20, 2025
- Date of Event
- July 23, 2025
- Report Date
- September 23, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270002525
- PMA / PMN Number
- K213919
- Removal / Correction Number
- Z-1944-2025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
(B)(4). 3004753838-2025-231143-01 WAS REPORTED IN ERROR. THE RECALL INFORMATION SHOULD HAVE BEEN INCLUDED IN THE H7 AND H9 OF THE PREVIOUS SUPPLEMENTAL.
(B)(4). D9: DEVICE AVAILABLE FOR EVALUATION - CORRECTION - INV WAS CREATED BY MISTAKE. FFA LAB NEVER RECEIVED THE PRODUCT FOR INVESTIGATION. THE BOT CREATED INV.
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.
SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS REQUIRED.
SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS REQUIRED.
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2410688 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 17198929 | 00386270002525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male |