FDA Adverse Event
Malfunction
Summary report: N
EVERSENSE SENSOR
MDR report key: 23861406
·
Received December 21, 2025
Report
- Report Number
- 3009862700-2025-02046
- Event Type
- Malfunction
- Date Received
- December 21, 2025
- Date of Event
- November 21, 2025
- Report Date
- February 19, 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
Additional Manufacturer Narrative · 0
THE RMA WAS AUTHORIZED BUT NOT RECEIVED, THUS NO CONFIRMATION OR INVESTIGATION OF THE COMPLAINT WAS POSSIBLE. B4.DATE OF THIS REPORT 19 FEB 2026. G3.DATE RECEIVED BY THE MANUFACTURER? 19 FEB 2026. H3. DEVICE EVALUATED BY MANUFACTURER?NO. H6. TYPE OF INVESTIGATION UPDATED TO 4114. H6. INVESTIGATION FINDINGS UPDATED TO 3221. H6. INVESTIGATION CONCLUSIONS UPDATED TO 67.
Additional Manufacturer Narrative · 0
D2B.CORRECTED FROM SBA TO QHJ.
Additional Manufacturer Narrative · 0
THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 0
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 |
|---|---|---|---|---|---|---|---|
| 2256733 | EVERSENSE SENSOR | IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR | QHJ | SENSEONICS INC. | 101967-950 | 2001020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |