FDA Adverse Event
Injury
Summary report: N
EVERSENSE SENSOR
MDR report key: 23891539
·
Received December 24, 2025
Report
- Report Number
- 3009862700-2025-02041
- Event Type
- Injury
- Date Received
- December 24, 2025
- Date of Event
- November 19, 2025
- Report Date
- January 15, 2026
- Manufacturer
- SENSEONICS INC.
- Product Code
- QHJ
- PMA / PMN Number
- P160048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 0
D2B.CORRECTED FROM SBA TO QHJ.
Description of Event or Problem · 0
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE HCP WAS UNABLE TO REMOVE THE USER'S PREVIOUS SENSOR, WHICH WAS INSERTED IN THE LEFT ARM. THE SENSOR WAS NOT PALPABLE PRIOR TO THE REMOVAL ATTEMPT, AND BOTH ULTRASOUND AND A MAGNET WERE USED TO LOCALIZE IT. AN X-RAY IS PLANNED TO ASSIST WITH LOCALIZATION DURING THE NEXT REMOVAL ATTEMPT AT THE TIME OF THE NEXT SENSOR EXCHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157669 | EVERSENSE SENSOR | IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR | QHJ | SENSEONICS INC. | 101967-950 | WP09972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |