BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 21308465 · Received February 4, 2025

    Report

    Report Number
    3009862700-2025-00175
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    November 13, 2024
    Report Date
    February 4, 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

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY AS PART OF INTERNAL REVIEW.THE USER REPORTED DISCREPANCIES BETWEEN THE BG AND SG READINGS. THE CASE WAS ESCALATED TO NEXT LEVEL SUPPORT FOR FURTHER ASSISTANCE. IT WAS RECOMMENDED THAT THE USER PERFORM A FIRMWARE UPGRADE. CUSTOMER CARE MADE MULTIPLE ATTEMPTS TO REACH THE USER TO PERFORM THE UPGRADE, BUT THE USER WAS UNRESPONSIVE. AS SUCH, NO FURTHER TROUBLESHOOTING WAS POSSIBLE.

    Description of Event or Problem · 0

    SENSONICS WAS MADE AWARE OF AN INCIDENT IN WHICH A USER REPORTED SENSOR INACCURACIES WHILE USING THE SYSTEM.NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE USER PROVIDED ADDITIONAL EXAMPLES FROM 13 NOVEMBER 2024: · 13 NOVEMBER 2024: · BG: 45 MG/DL / SG: 90 MG/DL. · BG: 48 MG/DL / SG: 94 MG/DL. · BG: 46 MG/DL / SG: 90 MG/DL. THE CASE HAS BEEN ESCALATED TO NEXT LEVEL OF SUPPORT FOR FURTHER ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48403 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 01E274S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female