FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6062330
·
Received October 27, 2016
Report
- Report Number
- 3004753838-2016-09191
- Event Type
- Malfunction
- Date Received
- October 27, 2016
- Date of Event
- October 7, 2016
- Report Date
- October 8, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000262
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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 ERR68. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND "CALL TECH SUPPORT" ERROR WAS OBSERVED ON THE SCREEN. THE DATA LOG COULD NOT BE RETRIEVED AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE OF THE "CALL TECH SUPPORT" ERROR. THE CUSTOMER COMPLAINT WAS CONFIRMED BECAUSE ERROR ICON WAS DISPLAYED. THE ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712515 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT22719-PNK | 5215855 | 00386270000262 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |