BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    MDR report key: 19365747 · Received May 21, 2024

    Report

    Report Number
    3013756811-2024-85604
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 26, 2024
    Report Date
    May 21, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 MULTIPLE INTERMITTENT ALTITUDE ALARMS OCCURRED WHILE THE CUSTOMER WAS NOT OUTSIDE OF LABELED OPERATING ALTITUDE RANGE. REPORTEDLY, ON ONE OCCASION, AN OBSTRUCTION WAS BLOCKING THE SPEAKER HOLES. AFTER REMOVING THE OBSTRUCTION FROM THE SPEAKER HOLES, THE ALARM CLEARED. ON A SEPARATE OCCASION THE CUSTOMER RELOADED THE CARTRIDGE TO ADDRESS THE ISSUE AND CLEAR THE ALARM. THE CUSTOMER'S BLOOD GLUCOSE RANGED FROM 200-237 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565889 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female