EVERSENSE SENSOR
Report
- Report Number
- 3009862700-2025-01391
- Event Type
- Malfunction
- Date Received
- September 19, 2025
- Date of Event
- August 19, 2025
- Report Date
- January 15, 2026
- Manufacturer
- SENSEONICS, INC
- Product Code
- QHJ
- PMA / PMN Number
- P160048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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.
A REVIEW OF THE TRANSMITTER ALERT HISTORY SHOWED SENSOR REPLACEMENT ALERT WAS FIRST PRESENTED TO THE CUSTOMER ON (B)(6) 2025, DAY 140 AFTER INSERTION. IN-HOUSE TESTING OF SENSOR (B)(6) SHOWED THAT THE SENSOR WAS CHEMICALLY UNDERPERFORMING. A REVIEW OF THE IN VIVO DATA FROM DMS SHOWED DIMINISHED SENSOR PERFORMANCE AS THE SIGNAL STEADILY DECLINED AND THE MSP GRADUALLY DECREASED TO THE THRESHOLD VALUE THROUGHOUT THE INSERTION PERIOD. THIS IS INDICATIVE OF HYDROGEL OXIDATION AND THE SYSTEM CORRECTLY DISABLED THE SENSOR DUE TO PERFORMANCE FAILURE. B4.DATE OF THIS REPORT 17 NOV 2025. G3.DATE RECEIVED BY THE MANUFACTURER? 17 NOV 2025. 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.
ON (B)(6 2025, 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 |
|---|---|---|---|---|---|---|---|
| 246973 | EVERSENSE SENSOR | IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR | QHJ | SENSEONICS, INC | 101967-950 | WP09966 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |