FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6289676
·
Received January 31, 2017
Report
- Report Number
- 3004753838-2017-09915
- Event Type
- Malfunction
- Date Received
- January 31, 2017
- Date of Event
- January 7, 2017
- Report Date
- January 7, 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
SR-984193 THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(4) 2017, PATIENT EXPERIENCED A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND 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 |
|---|---|---|---|---|---|---|---|
| 72137 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | 9438-06 | 5212245 | 10386270000221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |