FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8237183
·
Received January 10, 2019
Report
- Report Number
- 3004753838-2019-05086
- Event Type
- Malfunction
- Date Received
- January 10, 2019
- Date of Event
- December 13, 2018
- Report Date
- January 10, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). LOT # CORRECTION "5241429. " DEVICE MANUFACTURE DATE CORRECTION "20-JUL-2018."
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION COULD NOT BE DETERMINED. THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THE PRODUCT WAS EVALUATED. THE DEVICE WAS VISUALLY INSPECTED AND PASSED. A VOLTAGE TEST WAS PERFORMED AND IT PASSED. A PAIRING TEST WAS PERFORMED AND IT PASSED. THE LOG WAS DOWNLOADED AND REVIEWED FINDING A LOSS OF CONNECTION. THE ALLEGATION WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28035 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-02 | 5242305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |