FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 14579202
·
Received June 2, 2022
Report
- Report Number
- 3004753838-2022-090340
- Event Type
- Malfunction
- Date Received
- June 2, 2022
- Date of Event
- May 10, 2022
- Report Date
- June 2, 2022
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE LEH, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2022. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE TRANSMITTER STALE STOP COMMAND. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2413934 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-24 | 5302337 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Male |