BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 12366489 · Received August 25, 2021

    Report

    Report Number
    3013756811-2021-90390
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    August 6, 2021
    Report Date
    August 25, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00085006613373
    PMA / PMN Number
    DEN180058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP BASAL AND BOLUS HISTORY WAS MISSING DATA DESPITE THE PUMP BEING IN USE. REPORTEDLY, THE CUSTOMER EXITED THE PUMP HISTORY MENU AND NOTICED THAT THE BASAL AND BOLUS HISTORY WAS DISPLAYED AFTER RE-ENTERING THE HISTORY MENU. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 210-215 MG/DL. REPORTEDLY, CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264415 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00085006613373

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR