FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8405874
·
Received March 8, 2019
Report
- Report Number
- 3004753838-2019-24549
- Event Type
- Malfunction
- Date Received
- March 8, 2019
- Date of Event
- February 20, 2019
- Report Date
- March 8, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270000385
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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) 2019, THAT ON (B)(6) 2019, A LOSS OF CONNECTION OCCURRED. DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION WAS CONFIRMED. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APPLICATION WERE UNABLE TO ESTABLISH A CONNECTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
ADD D2: DEVICE PRODUCT CODE QBJ - ADDITIONAL INFORMATION OMITTED IN ERROR
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195829 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-02 | 5248530 | 00386270000385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |