FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6168331
·
Received December 12, 2016
Report
- Report Number
- 3004753838-2016-58387
- Event Type
- Malfunction
- Date Received
- December 12, 2016
- Date of Event
- November 13, 2016
- Report Date
- November 14, 2016
- Manufacturer
- DEXCOM INC.
- Product Code
- MDS
- UDI-DI
- 00386270000224
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 11/14/2016, THAT ON (B)(6) 2016, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. DATA REVIEW CONFIRMED THE REPORTED EVENT OF A LOSS OF CONNECTION. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 817684 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM INC. | 9438-06 | 5215741 | 00386270000224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | (B)(6) |