FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 9603611
·
Received January 17, 2020
Report
- Report Number
- 3004753838-2020-005500
- Event Type
- Malfunction
- Date Received
- January 17, 2020
- Date of Event
- December 20, 2019
- Report Date
- January 17, 2020
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
HI THE APP KEEPS CLOSING DOWN IM USING A (B)(6) PHONE. IS THERE SOMETHING WRONG WITH IT OR THE APP? 12/22/2019 (B)(4): EMAIL SENT TO (B)(6); 12/22/2019 (B)(4): NO PHONE # ON FILE. SENT COURTESY EMAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63970 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 118 YR |