DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-204764
- Event Type
- Injury
- Date Received
- August 15, 2024
- Date of Event
- July 19, 2024
- Report Date
- August 16, 2024
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270004109
- PMA / PMN Number
- K213919
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4).
IT WAS REPORTED THAT DAMAGED SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF-LABEL USAGE OF THE DEVICE. ON 07/19/2024, THE EMERGENCY ROOM (ER) PHYSICIAN REPORTED THAT THE PEDIATRIC PATIENT EXPERIENCED DAMAGED WIRE AFTER REMOVAL WHICH OCCURRED AFTER THE SENSOR HAD BEEN INSERTED IN THE ABDOMEN. ACCORDING TO THE COMPLAINT, THE PATIENT HAD TWO RETAINED WIRES ON EITHER SIDE OF THE ABDOMEN (RELATED SR 240719-012925/(B)(4) AT THE TIME OF THE REPORT, THE PATIENT WAS IN THE ER AND HAD UNDERGONE X-RAY AND COMPUTED TOMOGRAPHY (CT) SCAN, AND WAS ABOUT TO UNDERGO SURGERY TO REMOVE THE WIRES. ATTEMPTS TO CONTACT THE REPORTER/PARENT ABOUT THE OUTCOME OF THE EVENT WERE NOT SUCCESSFUL. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. NO OTHER DETAILS WERE DOCUMENTED. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1201735 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | NI | 00386270004109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Male | Hospitalization| O |