FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7920863
·
Received September 28, 2018
Report
- Report Number
- 3004753838-2018-115511
- Event Type
- Malfunction
- Date Received
- September 28, 2018
- Date of Event
- August 19, 2018
- Report Date
- November 6, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270000385
- PMA / PMN Number
- P170031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, 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)(4) 2018 THAT THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6) 2018. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A TRANSMITTER FAILED ERROR WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE WAS DETERMINED TO BE A LOW TRANSMITTER BATTERY THAT LED TO A TRANSMITTER FAILURE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
PLEASE DISREGARD THE INFORMATION IN REPORT NUMBER 3004753838-2018-115511 AS THIS IS A DUPLICATE REPORT. THE INFORMATION CONTAINED IN THIS REPORT HAS PREVIOUSLY BEEN REPORTED ON MFR NUMBER 3004753838-2018-111390.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 759550 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-02 | 5240500 | 00386270000385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |