BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 22670360 · Received July 30, 2025

    Report

    Report Number
    3009862700-2025-01099
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    June 29, 2025
    Report Date
    July 30, 2025
    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

    Narratives

    Additional Manufacturer Narrative · 0

    USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS. THE CASE WAS ESCALATED TO THE NEXT LEVEL OF SUPPORT FOR ADDITIONAL REVIEW AND SENSOR RE-LINK WAS REQUESTED.THE RE-LINK WAS PERFORMED, AND THE USER WAS ENCOURAGED TO RESUME NORMAL USAGE OF THE SYSTEM AND TO CONTACT US IF ANY ADDITIONAL DIFFERENCES WERE SEEN.AS PER, DMS USER IS CURRENTLY USING THE SYSTEM WITH UP-TO-DATE INFORMATION.

    Description of Event or Problem · 0

    ON 20 JUNE 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN EVENT WHERE THE CGM SHOWED RESULTS THAT ARE DIFFERENT FROM GLUCOMETER MEASUREMENTS.NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515172 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 01F031S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female