FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM
MDR report key: 14462928
·
Received May 20, 2022
Report
- Report Number
- 3004753838-2022-082553
- Event Type
- Malfunction
- Date Received
- May 20, 2022
- Date of Event
- March 24, 2022
- Report Date
- May 20, 2022
- Manufacturer
- DEXCOM, INC.
- Product Code
- QDK
- PMA / PMN Number
- K203089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
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 |
|---|---|---|---|---|---|---|---|
| 552382 | DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM | CONTINUOUS GLUCOSE MONITOR | QDK | DEXCOM, INC. | 9445-24 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male |