BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 23359062 · Received October 22, 2025

    Report

    Report Number
    3013756811-2025-242630
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 17, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MEDWATCH WAS SUBMITTED INADVERTENTLY. AS THE REPORT WAS SUBMITTED VIA MFG REPORT #3013756811-2025-231721.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO REPORTED IMPACT TO CUSTOMER'S BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505473 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown