FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8122734
·
Received December 1, 2018
Report
- Report Number
- 3004753838-2018-150163
- Event Type
- Malfunction
- Date Received
- December 1, 2018
- Date of Event
- November 5, 2018
- Report Date
- November 6, 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). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED. (B)(4).
Description of Event or Problem · 1
UPON FURTHER REVIEW, THIS RECORD HAS BEEN DETERMINED TO NOT BE REPORTABLE. PLEASE DISREGARD INITIAL REPORTING UNDER MFR# 3004753838-2018-150163.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 , THAT THE SENSOR CODE ENTERED BUT WAS REVERTED TO CALIBRATION MODE WAS REPORTED. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2018. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA HAS BEEN RECEIVED BUT NOT YET EVALUATED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 961593 | DEXCOM G6 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-46 | 5241438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR |