BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22496614 · Received July 14, 2025

    Report

    Report Number
    3013756811-2025-166859
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 20, 2025
    Report Date
    July 24, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REMOVE A070504; ADD A150105.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS UNRESPONSIVE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AND DECLINED TO PROVIDE FURTHER INFORMATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT BATTERY LIFE WAS DIMINISHING BY 35-50% EACH DAY AND SCREEN RESPONSIVENESS WAS DEGRADING, REQUIRING MULTIPLE PRESSES FOR BUTTONS TO WORK. ADDITIONALLY, UNEXPLAINED ALERTS LIKE REPEATED OCCLUSION ALERTS OCCURRED EVEN AFTER REPLACING THE INFUSION SET. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING, AND THE CTS TASK TEAM WAS UNABLE TO CALCULATE BATTERY DEPLETION PERCENTAGE DUE TO MISSING LOGS. CONSEQUENTLY, THE CASE WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401605 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female