FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6057653
·
Received October 26, 2016
Report
- Report Number
- 3004753838-2016-72822
- Event Type
- Malfunction
- Date Received
- October 26, 2016
- Date of Event
- October 4, 2016
- Report Date
- October 4, 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 INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER LOG WAS REVIEWED AND FIRMWARE ERRORS WERE OBSERVED. THE REPORTED EVENT OF INITIALIZING SCREEN WITHOUT MANUAL RESTART WAS CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707496 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT22719-BLU | 5215858 | 00386270000279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |