FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 13078049
·
Received December 23, 2021
Report
- Report Number
- 3004753838-2021-433191
- Event Type
- Malfunction
- Date Received
- December 23, 2021
- Date of Event
- November 28, 2021
- Report Date
- December 23, 2021
- Manufacturer
- DEXCOM, INC.
- Product Code
- QDK
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2021. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. HOWEVER, THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1972528 | DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QDK | DEXCOM, INC. | 9445-24 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Female |