BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 11611895 · Received April 4, 2021

    Report

    Report Number
    3009862700-2021-00042
    Event Type
    Injury
    Date Received
    April 4, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 5, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491022349
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER CONFIRMED THAT NEW SENSOR HAS BEEN INSERTED AND THE EXPIRED SENSOR HAS BEEN REMOVED SUCCESSFULLY ON (B)(6) 2021. USER WAS DOING FINE AND NO MEDICATIONS WERE PRESCRIBED.

    Description of Event or Problem · 1

    ON MARCH 05TH 2021, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER GOT INSERTED WITH AN EXPIRED SENSOR AND NEEDS TO BE REPLACED. USER CONFIRMED THAT THE NEW SENSOR HAD BEEN INSERTED AND EXPIRED SENSOR WAS SUCCESSFULLY REMOVED ON (B)(6) 2021. USER WAS DOING FINE AND NO MEDICATIONS WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509290 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102096-67A WP06619 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR