FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6205200
·
Received December 27, 2016
Report
- Report Number
- 3004753838-2016-93758
- Event Type
- Malfunction
- Date Received
- December 27, 2016
- Date of Event
- December 4, 2016
- Report Date
- December 4, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000279
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
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 COULD NOT BE CONFIRMED BECAUSE IT COULD NOT BE DETERMINED IF ANY ERROR OCCURRED ON THE DATE OF EVENT. THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE RECEIVER DISPLAYED AN ERROR 281. 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 |
|---|---|---|---|---|---|---|---|
| 854387 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT22719-BLU | 5220643 | 00386270000279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |