FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5510186
·
Received March 18, 2016
Report
- Report Number
- 3004753838-2016-01858
- Event Type
- Malfunction
- Date Received
- March 18, 2016
- Date of Event
- February 24, 2016
- Report Date
- February 24, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000224
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT THAT ON (B)(6) 2016, THE G5 TRANSMITTER WOULD NOT PAIR WITH THE G5 APPLICATION. PATIENT VERIFIED SMART DEVICE IS NOT AIRPLANE MODE, WI-FI IS ENABLED, NO OTHER APPLICATIONS WERE RUNNING IN THE BACKGROUND, AND THE BATTERY LEVEL IS AT 100%. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167050 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9438-06 | 5208141 | 00386270000224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | (B)(6) |