DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-000490
- Event Type
- Malfunction
- Date Received
- January 2, 2024
- Date of Event
- December 9, 2023
- Report Date
- July 22, 2024
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270002198
- PMA / PMN Number
- K213919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL. D9: DEVICE AVAILABILITY - ADDITIONAL. H2: CORRECTION/ADDITIONAL INFORMATION/DEVICE EVALUATION. H3: DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL. H6: ADVERSE EVENT PROBLEM - CORRECTION/ADDITIONAL. PLEASE DISREGARD THE H6 CODE "4101", AS IT WAS SUBMITTED IN ERROR UNDER THE INTIAL SUBMISSION (3004753838-2024-000490). THE CORRECT H6 CODE SHOULD BE 4114 UNDER MFR (3004753838-2024-000490).
IT WAS REPORTED THAT THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A RECEIVER CHARGE AND BOOT WAS PERFORMED AND FAILED DUE TO RECEIVER PERPETUALLY REBOOTING. A RECEIVER DOWNLOAD WAS ATTEMPTED BUT COULD NOT BE COMPLETED DUE TO RECEIVER PERPETUALLY REBOOTING. CONFIRMATION OF THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1213651 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 00386270002198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male |