EVERSENSE SENSOR
Report
- Report Number
- 3009862700-2025-02022
- Event Type
- Injury
- Date Received
- December 31, 2025
- Date of Event
- November 28, 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
THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.
D2B.CORRECTED FROM SBA TO QHJ.
THE USER REPORTED THEY WERE HOSPITALIZED DUE TO A PLANNED SURGERY. THE USER DIDN'T WANT TO SHARE THE DIAGNOSIS. THE EVENT HAPPENED ON 28-NOV-2025 AT 8:00 AM. AT THE TIME OF THE CALL, THE USER WAS FEELING FINE. THE EVENT WAS NOT RELATED TO THE SENSOR INSERTION OR REMOVAL. THE EVENT WAS NOT RELATED TO DIABETES OR GLUCOSE MEASUREMENTS. ER DMS, THE USER HAS NOT BEEN USING THE SYSTEM SINCE (B)(6) 2025 AT 7:41 AM, DUE TO THE HOSPITALIZATION. SINCE THIS EVENT WAS UNRELATED TO THE USE OF EVERSENSE E3 CGM SYSTEM, NO ADDITIONAL INVESTIGATION WAS FOUND NECESSARY FOR THIS COMPLAINT.
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED WAS HOSPITALIZED DUE TO A PLANNED SURGERY ON (B)(6) 2025 AT 8:00 AM AND CHOSE NOT TO SHARE THE DIAGNOSIS; AT THE TIME OF THE CALL, THE USER WAS FEELING FINE. THE EVENT WAS NOT RELATED TO THE SENSOR INSERTION OR REMOVAL AND WAS NOT RELATED TO DIABETES OR GLUCOSE MEASUREMENTS. PER THE DATA MANAGEMENT SYSTEM (DMS), THE USER HAS NOT BEEN USING THE SYSTEM SINCE (B)(6) 2025 AT 7:41 AM DUE TO THE HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286199 | EVERSENSE SENSOR | IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR | QHJ | SENSEONICS INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |