FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6106542
·
Received November 16, 2016
Report
- Report Number
- 3004753838-2016-53222
- Event Type
- Malfunction
- Date Received
- November 16, 2016
- Date of Event
- October 13, 2016
- Report Date
- October 25, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000262
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
THE COMPLAINT RECEIVER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND "CALL TECH SUPPORT" ERROR WAS OBSERVED ON THE SCREEN. PICTURES OF THE DISPLAY WERE TAKEN. 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 A LOSS OF CONNECTION OCCURRED. THE ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 755902 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT22719-PNK | 5216953 | 00386270000262 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |