BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 23320148 · Received October 17, 2025

    Report

    Report Number
    3013756811-2025-239199
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    October 9, 2025
    Report Date
    October 16, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152407111
    PMA / PMN Number
    K232380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED WITHIN THE INFUSIONS SET TUBING. CUSTOMER PERFORMED A SUPPLY CHANGE TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 445 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2471207 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152407111

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female LISPRO - INSULIN| TANDEM - CARTRIDGE| UNOMEDICAL - INFUSION SET