FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7924307
·
Received October 1, 2018
Report
- Report Number
- 3004753838-2018-116109
- Event Type
- Malfunction
- Date Received
- October 1, 2018
- Date of Event
- September 2, 2018
- Report Date
- September 3, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- P170031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 09/03/2018, THAT ON (B)(6) 2018, THE G6 MOBILE APPLICATION SHUTS OFF UNEXPECTEDLY. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED UNEXPECTED G6 MOBILE APPLICATION SHUT-OFF WAS NOT CONFIRMED VIA DATA. THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 09/03/2018, THAT ON (B)(6) 2018, AN APP CRASH ALERT OCCURRED. THE REPORTED APP CRASH ALERT WAS NOT CONFIRMED VIA DATA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 764454 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |