BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22372303 · Received July 1, 2025

    Report

    Report Number
    3013756811-2025-155382
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    May 14, 2025
    Report Date
    October 8, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: REMOVED CODE A070803; ADDED CODES A0706, A141204.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEIR PUMP WAS NOT CHARGING. TECHNICAL SUPPORT ATTEMPTED TO CHARGE THE PUMP USING DIFFERENT CABLES; HOWEVER, THE PUMP DID NOT TURN ON AND THE WAKE BUTTON WAS FLASHING RED. THE BLOOD GLUCOSE LEVEL WAS REPORTED AS 100 MG/DL. A REPLACEMENT PUMP HAS BEEN SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207172 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