BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 23822469 · Received December 16, 2025

    Report

    Report Number
    3009862700-2025-02000
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 14, 2025
    Report Date
    February 14, 2026
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    UDI-DI
    00817491024282
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE USER COMPLAINED ABOUT RECEIVING GLUCOSE SUSPEND ALERT ON (B)(6) 2025. AN RMA WAS AUTHORIZED FOR THE RETURN OF THE SENSOR FOR FURTHER INVESTIGATION. THE SENSOR WAS RETURNED AND TESTED IN-HOUSE, AND THE ANALYSIS SHOWED NO ISSUES WITH ITS CHEMICAL PERFORMANCE. A REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS) DATA SHOWED OPTICAL INSTABILITY IN ONE OF THE SENSING AREAS. THIS INSTABILITY COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING, WHICH CAN OCCUR WHEN THE FAILURE MODE OBSERVED IN VIVO IS NOT REPLICATED UNDER LABORATORY CONDITIONS. ADDITIONALLY, THE DMS DATA REVEALED FREQUENT MISSED READS DUE TO INTERNAL ELECTRICAL COMMUNICATION ISSUES. THE COMBINATION OF THESE FACTORS RESULTED IN GLUCOSE BLINDING TRIGGERED BY THE SYSTEM'S SELF-CHECKS, LEADING TO THE ACTIVATION OF THE GLUCOSE SUSPEND ALERTS. THE USER WAS PROVIDED WITH A REPLACEMENT SENSOR AS PART OF THE RESOLUTION. B4.DATE OF THIS REPORT 14 FEB 2026. G3.DATE RECEIVED BY THE MANUFACTURER? 14 FEB 2026. H3. DEVICE EVALUATED BY MANUFACTURER?YES. H6. TYPE OF INVESTIGATION UPDATED TO 10,4121. H6. INVESTIGATION FINDINGS UPDATED TO 628,3224. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4307,4315.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED OF RECEIVING GLUCOSE SUSPEND ALERTS WHICH LED TO EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2281126 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 01F031S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown