FDA Adverse Event
Injury
Summary report: N
EVERSENSE SENSOR
MDR report key: 23601387
·
Received November 19, 2025
Report
- Report Number
- 3009862700-2025-01856
- Event Type
- Injury
- Date Received
- November 19, 2025
- Date of Event
- October 20, 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
- IS
- 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. AN INCISION WAS MADE, AND THE USER IS CURRENTLY DOING WELL. THE SENSOR WAS PALPABLE, AND THE TRANSMITTER WAS USED FOR LOCALIZATION; HOWEVER, EXTRACTION WAS UNSUCCESSFUL. THE NEXT SENSOR REMOVAL IS PLANNED IN SIX MONTHS USING ULTRASOUND GUIDANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2661212 | EVERSENSE SENSOR | IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR | QHJ | SENSEONICS INC. | WP09925 | WP09925 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |