FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6327129
·
Received February 13, 2017
Report
- Report Number
- 3004753838-2017-14230
- Event Type
- Malfunction
- Date Received
- February 13, 2017
- Date of Event
- January 21, 2017
- Report Date
- January 21, 2017
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 10386270000221
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 01/21/2017 THAT ON 01/21/2017, THERE WAS A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND THE SMART DEVICE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 108008 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | 9438-06 | 5214226 | 10386270000221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR |