BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 19876088 · Received July 31, 2024

    Report

    Report Number
    3013756811-2024-136930
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 13, 2024
    Report Date
    July 31, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP INDICATED A DATA LOG CORRUPTION. REPORTEDLY, CUSTOMER CONTINUED USING PUMP FOR INSULIN THERAPY. ADDITIONALLY, IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY A NEW CARTRIDGE WAS LOADED, AND INSULIN DELIVERY WAS RESUMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 120 - 203 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739742 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female