FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
MDR report key: 6120931
·
Received November 22, 2016
Report
- Report Number
- 3004753838-2016-51756
- Event Type
- Malfunction
- Date Received
- November 22, 2016
- Date of Event
- November 3, 2016
- Report Date
- November 3, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000156
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2016 THAT THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART ON (B)(6) 2016. THERE WAS NO REPORT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. A VISUAL EXTERIOR INSPECTION WAS PERFORMED AND IT PASSED. THE RECEIVER LOG WAS REVIEWED, FINDING NO ERRORS. A GLOBAL RECEIVER FUNCTIONAL TEST WAS PERFORMED AND IT PASSED, FINDING NO FAILURE. THE COMPLAINT OF RECEIVER INITIALIZATION WITHOUT A MANUAL RESTART COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771613 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT22495 | 5216822 | 00386270000156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |