FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 17334308
·
Received July 17, 2023
Report
- Report Number
- 3004753838-2023-139887
- Event Type
- Malfunction
- Date Received
- July 17, 2023
- Date of Event
- June 18, 2023
- Report Date
- July 17, 2023
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270001627
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
3004753838-2023-140260
Description of Event or Problem · 0
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR 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 |
|---|---|---|---|---|---|---|---|
| 1714987 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-24 | P16265724 | 00386270001627 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male |