BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22485483 · Received July 11, 2025

    Report

    Report Number
    3013756811-2025-165666
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 14, 2025
    Report Date
    July 16, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319612
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DUPLICATE OF MFR#3013756811-2025-163401.

    Description of Event or Problem · 0

    A MALFUNCTION ALARM WAS REPORTED BY THE CALLER. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER FOLLOWED UP, COMPLETED TROUBLESHOOTING WITH TECHNICAL SUPPORT, AND NO FURTHER ASSISTANCE WAS NEEDED, LEADING TO THE CASE BEING CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678808 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152319612

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female