BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22907277 · Received August 27, 2025

    Report

    Report Number
    3013756811-2025-203309
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 20, 2025
    Report Date
    January 30, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: REMOVED CODE A0902, ADDED CODE A150105.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PUMP DISPLAY WAS UNRESPONSIVE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER ATTEMPTED A PUMP RESET, BUT THE ISSUE PERSISTED. CUSTOMER REVERTED TO USING A BACKUP THERAPY OF MULTIPLE DAILY INJECTIONS (MDI) TO ENSURE CONTINUOUS INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312875 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