DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2025-340100
- Event Type
- Malfunction
- Date Received
- December 11, 2025
- Date of Event
- November 22, 2025
- Report Date
- January 16, 2026
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270004109
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED FREQUENTLY BETWEEN 11/202/2025 AND 11/23/2025. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO THE FINDING OF SIGNAL LOSS OVER AN HOUR WAS FOUND OCCASIONALLY WITHIN THE INVESTIGATION WINDOW. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED FREQUENTLY BETWEEN 11/20/2025 AND11/23/2025. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND PASSED. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO THE FINDING OF SIGNAL LOSS OVER ONE HOUR OCCASIONALLY AS INVESTIGATED WITHIN THE INVESTIGATION WINDOW. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2718238 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1825220012 | 00386270004109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male |