FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8026985
·
Received October 31, 2018
Report
- Report Number
- 3004753838-2018-133908
- Event Type
- Malfunction
- Date Received
- October 31, 2018
- Date of Event
- October 5, 2018
- Report Date
- October 5, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- P170031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). PLEASE DISREGARD ALL INFORMATION THAT WAS REPORTED IN THE INITIAL MDR FOR REPORT NUMBER 3004753838-2018-133908 AS THIS IS A DUPLICATE REPORT. THIS CUSTOMER COMPLAINT HAS BEEN PREVIOUSLY REPORTED IN REPORT NUMBER 3004753838-2018-132831.
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 PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA HAS BEEN RECEIVED BUT NOT YET EVALUATED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 866428 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-02 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |