FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 11216517
·
Received January 22, 2021
Report
- Report Number
- 3004753838-2021-16356
- Event Type
- Malfunction
- Date Received
- January 22, 2021
- Date of Event
- January 3, 2021
- Report Date
- January 22, 2021
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270000385
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A TRANSMITTER FAILED ERROR OCCURRED FOR TRANSMITTER ID (B)(4). DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED FOR TRANSMITTER ID (B)(4). THE PROBABLE CAUSE COULD NOT BE DETERMINED POST INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110079 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-02 | 5269922 | 00386270000385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |