FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8372290
·
Received February 26, 2019
Report
- Report Number
- 3004753838-2019-021545
- Event Type
- Malfunction
- Date Received
- February 26, 2019
- Date of Event
- January 27, 2019
- Report Date
- February 25, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270000804
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: COM-0111732-19, 190129-003236.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2019 THAT ON (B)(6) 2019, A LOSS OF CONNECTION OCCURRED FOR AN UNKNOWN LENGTH OCCURRED. DATA INVESTIGATION COMPLETED ON (B)(6) 2019 CONFIRMED A LOSS OF CONNECTION GREATER THAN AN HOUR. THE PROBABLE CAUSE WAS DETERMINED TO BE NO COMMUNICATION ¿ GAP IN LOGS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162305 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | N/A | 00386270000804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |