BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22701891 · Received August 4, 2025

    Report

    Report Number
    3013756811-2025-184108
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 21, 2025
    Report Date
    October 14, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DUPLICATE OF 3013756811-2025-180207.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP SCREEN WAS DARK AND UNRESPONSIVE, WITH NO LED LIGHT BLINKING. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS MEASURED AT 306 MG/DL, WHICH IS WITHIN THE NORMAL RANGE OF 54-500 MG/DL, INDICATING NO ADVERSE IMPACT. TECHNICAL SUPPORT INSTRUCTED THE CALLER TO TRY DIFFERENT TROUBLESHOOTING METHODS, INCLUDING PRESSING THE PUMP BUTTON AND USING DIFFERENT CHARGING SUPPLIES, BUT THE PUMP REMAINED UNRESPONSIVE. ULTIMATELY, TECHNICAL SUPPORT DECIDED TO REPLACE THE PUMP, ENSURING THE CUSTOMER WOULD USE AN ALTERNATE METHOD, MULTIPLE DAILY INJECTIONS (MDI), FOR INSULIN DELIVERY IN THE MEANTIME. THE CALLER WAS INSTRUCTED ON HOW TO PUT THE PUMP INTO STORAGE MODE AND TO RETURN IT WITH A PRE-PAID LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584538 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