BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE TRANSMITTER

    MDR report key: 11943511 · Received June 4, 2021

    Report

    Report Number
    3009862700-2021-00078
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 6, 2021
    Report Date
    May 6, 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

    UPON ANALYSIS OF THE SYSTEM ON THE 6TH OF MAY 2021, IT WAS OBSERVED THAT THE SYSTEM HAD FIRST ASSERTED LOW GLUCOSE ALERT AT 7:36 PM EST, WHICH IS APPROXIMATELY 1 HOUR BEFORE THE CUSTOMER SUPPORT CALL WAS MADE. DURING THE CALL THE USER MENTIONED THE SYSTEM WAS IN SENSOR SUSPEND PHASE AND DID NOT ALLOW THE USER TO ENTER CALIBRATION FOR 6 HOURS, WHICH IS PER DESIGN. THE USER EXPRESSED HYPOGLYCEMIC SYMPTOMS WHILE ON THE CALL AND AT THIS TIME THE SYSTEM WAS ALREADY IN SENSOR SUSPEND PHASE AND THERE WERE NO SENSOR GLUCOSE READINGS DISPLAYED ON THE APP. THE SYSTEM HAD STARTED TO ALERT THE USER OF THE HYPO EVENT AROUND 7:36 PM EST ON (B)(6) 2021, APPROXIMATELY AN HOUR BEFORE THE USER CALLED TO REPORT THE SENSOR SUSPEND ALERT. PER DMS ALERT HISTORY PAGE, THE LOW GLUCOSE ALERTS WERE ASSERTED AND DISPLAYED ON THE APP UNTIL 8:11 PM EST JUST BEFORE THE SENSOR SUSPEND ALERT AT 8:16 PM EST, AT WHICH POINT, THE SYSTEM STOPPED DISPLAYING GLUCOSE RELATED ALERTS AS GLUCOSE WAS BLINDED. THIS IS PER DESIGN. THERE IS NO FURTHER INVESTIGATION NEEDED AT THIS TIME AS THE SYSTEM DID ALERT THE USER OF THE HYPO EVENT.

    Description of Event or Problem · 1

    ON MAY 06TH 2021, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER EXPRESSED HYPOGLYCEMIC SYMPTOMS WHILE ON THE CALL AND AT THIS TIME THE SYSTEM WAS ALREADY IN SENSOR SUSPEND PHASE AND THERE WERE NO SENSOR GLUCOSE READINGS DISPLAYED ON THE APP.USER DID NOT PROVIDE DATE AND TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839581 EVERSENSE TRANSMITTER EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102208-500 117558 00817491021441

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR