BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 21327707 · Received February 6, 2025

    Report

    Report Number
    3009862700-2025-00181
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    December 4, 2024
    Report Date
    February 6, 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 SG AND BG VALUES.THE CASE WAS ESCALATED TO NEXT LEVEL SUPPORT FOR FURTHER ASSISTANCE. UPON REVIEW, IT WAS DETERMINED THAT THERE WAS SOME VARIABILITY IN THE USER'S SYSTEM. CUSTOMER CARE MADE MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE USER TO CONTINUE THE TROUBLESHOOTING PROCESS, BUT NO RESPONSE WAS RECEIVED AND NO FURTHER ASSISTANCE COULD BE PROVIDED.

    Description of Event or Problem · 0

    SENSONICS WAS MADE AWARE OF AN INCIDENT IN WHICH A USER REPORTED DISCREPANCIES BETWEEN THE SG AND BG VALUES. (B)(6) 2024: · BG: 82 MG/DL / SG: 115 MG/DL, · BG: 77 MG/DL / SG: 106 MG/DL, · BG: 74 MG/DL / SG: 101 MG/DL. THE CASE WAS ESCALATED TO NEXT LEVEL SUPPORT FOR FURTHER ASSISTANCE.NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918283 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 01E274S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male