BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 24229094 · Received February 2, 2026

    Report

    Report Number
    3009862700-2026-00191
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    December 30, 2025
    Report Date
    January 30, 2026
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    UDI-DI
    00817491024282
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER REPORTED AN "ELECTRIC SENSATION" AT THE SENSOR INSERTION SITE. THE USER WENT TO THE ER BUT WAS NOT SEEN OR TREATED AND LEFT. THE SENSOR WAS LATER REMOVED BY AN HEALTH CARE PROFESSIONAL.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN "ELECTRIC SENSATION" AT THE SENSOR SITE. THE USER WENT TO THE ER BUT WAS NOT SEEN OR TREATED AND LEFT. THE SENSOR WAS LATER REMOVED BY AN HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291638 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 01F237S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other