FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6179467
·
Received December 15, 2016
Report
- Report Number
- 3004753838-2016-94486
- Event Type
- Malfunction
- Date Received
- December 15, 2016
- Date of Event
- August 31, 2016
- Report Date
- August 31, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000002
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016 ,THERE WAS NO ALERTS COMING FROM THE G5 MOBILE APPLICATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 825492 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | NA | NA | 00386270000002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |