FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 24042953
·
Received January 12, 2026
Report
- Report Number
- 3004753838-2026-031807
- Event Type
- Malfunction
- Date Received
- January 12, 2026
- Date of Event
- August 25, 2024
- Report Date
- January 12, 2026
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270001870
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
3004753838-2026-031807
Description of Event or Problem · 0
DEXCOM BECAME AWARE THAT THE USER EXPERIENCED A FAILURE BUT DID NOT RECEIVE THE EXPECTED SENSOR FAILURE ALERT ON THEIR G7 CGM APPLICATION. DATA WAS PROVIDED AND AN INVESTIGATION WAS PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE A CODING ISSUE. THE G7 CGM APPLICATION ONLY DETECTS THAT THE SESSION HAS ENDED, THUS, IT DOES NOT ALERT THE USER THAT THE SENSOR HAS FAILED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102753 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1824116003 | 00386270001870 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |