FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 PROFESSIONAL SYSTEM
MDR report key: 11742630
·
Received April 28, 2021
Report
- Report Number
- 3004753838-2021-76658
- Event Type
- Malfunction
- Date Received
- April 28, 2021
- Date of Event
- April 25, 2021
- Report Date
- April 28, 2021
- Manufacturer
- DEXCOM, INC.
- Product Code
- QII
- PMA / PMN Number
- K191833
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632599 | DEXCOM G6 PROFESSIONAL SYSTEM | CONTINUOUS GLUCOSE MONITOR | QII | DEXCOM, INC. | 9445-20 | 5281473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |