BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE TRANSMITTER

    MDR report key: 11646066 · Received April 9, 2021

    Report

    Report Number
    3009862700-2021-00059
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 13, 2021
    Report Date
    March 17, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491021441
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE REPORTED PM7 CASE ON 13 MAR-2021, THE EVENT TIME AND BG ARE UNCLEAR. USER WAS ASSISTED BY THE FIRE RESCUE TO TREAT THE HYPOGLYCEMIA WITH IV FLUIDS. HOWEVER, THE INVESTIGATION SHOWS THAT CUSTOMER WAS PROVIDED LOW GLUCOSE ALERTS FROM 4:12 AM TO 6:17 AM. THE SYSTEM PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    ON MARCH 17TH 2021, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER EXPERIENCED HYPOGLYCEMIA AND EMERGENCY SERVICE WAS CALLED IN AND WAS ASSISTED BY FIRE RESCUE AND GIVEN IV FLUIDS TO TREAT HYPOGLYCEMIA. USER MENTIONED THE EXACT TIME OF EVENT AND BLOOD SUGAR IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542569 EVERSENSE TRANSMITTER EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102208-500 115099 00817491021441

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other