FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6105588
·
Received November 16, 2016
Report
- Report Number
- 3004753838-2016-84888
- Event Type
- Malfunction
- Date Received
- November 16, 2016
- Date of Event
- October 19, 2016
- Report Date
- October 19, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000279
- PMA / PMN Number
- P120005
- 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
DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED ERROR 121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 755890 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT22719-BLU | 5213193 | 00386270000279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |