EVERSENSE SENSOR
Report
- Report Number
- 3009862700-2025-01799
- Event Type
- Malfunction
- Date Received
- November 9, 2025
- Date of Event
- October 9, 2025
- Report Date
- January 15, 2026
- Manufacturer
- SENSEONICS INC.
- Product Code
- QHJ
- UDI-DI
- 00817491022950
- PMA / PMN Number
- P160048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
D2B.CORRECTED FROM SBA TO QHJ.
THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.
THE SENSOR REPLACEMENT ALERT WAS FIRST PRESENTED TO THE USER ON 9 OCT 2025, DAY 160 AFTER INSERTION. THE SENSOR WAS TESTED IN-HOUSE, AND THE REVIEW OF INVESTIGATION ANALYSIS REVEALED A LOSS OF CHEMICAL PERFORMANCE. THE SYSTEM CORRECTLY DISABLED THE SENSOR WHEN IT DETECTED THE PERFORMANCE FAILURE, AND THE SYSTEM'S SELF-TEST FUNCTIONS WERE WORKING NORMALLY. THE ROOT CAUSE OF THE PERFORMANCE FAILURE WAS DUE TO THE OXIDATION OF THE GLUCOSE INDICATING CHEMISTRY IN THE SENSOR HYDROGEL.THE USER WAS PROVIDED WITH A REPLACEMENT SENSOR AS PART OF THE RESOLUTION. B4.DATE OF THIS REPORT 08 JAN 2026. G3.DATE RECEIVED BY THE MANUFACTURER? 08 JAN 2026. H3. DEVICE EVALUATED BY MANUFACTURER?YES. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 3231. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4307.
SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40430 | EVERSENSE SENSOR | IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR | QHJ | SENSEONICS INC. | 102096-81A | 01E284S | 00817491022950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male |