BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 24041306 · Received January 12, 2026

    Report

    Report Number
    3013756811-2026-06911
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    January 7, 2026
    Report Date
    April 13, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319810
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER'S PUMP SCREEN WAS DARK AND WOULD NOT TURN ON, DESPITE VARIOUS TROUBLESHOOTING ATTEMPTS SUGGESTED BY CUSTOMER SUPPORT, SUCH AS PRESSING SPECIFIC BUTTONS AND PLUGGING IT INTO A POWER SOURCE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER TECHNICAL SUPPORT (CTS) DECIDED TO REPLACE THE PUMP, AS THE CURRENT ONE WAS STILL UNDER WARRANTY UNTIL JANUARY 23, 2027, ALTHOUGH THE SUPPORT TEAM WAS UNABLE TO REACH THE CUSTOMER AGAIN AFTER THE CALL WAS DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292596 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152319810

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Unknown