BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 23247716 · Received October 8, 2025

    Report

    Report Number
    3013756811-2025-232666
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    October 8, 2025
    Report Date
    February 6, 2026
    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

    Description of Event or Problem · 0

    CALLER REPORTED THAT PUMP TOUCHSCREEN WAS CRACKED AND SHATTERED, RENDERING IT UNRESPONSIVE AND LEADING TO AN INABILITY TO INTERACT WITH THE DEVICE. BLOOD GLUCOSE LEVEL WAS REPORTED WITHIN NORMAL RANGE, AS IT DID NOT EXCEED 500 MG/DL (27.7 MMOL/L). TO ADDRESS THE ISSUE, CTS ARRANGED A PUMP REPLACEMENT AND CONFIRMED THE SHIPPING ADDRESS WHILE INSTRUCTING THE CALLER TO USE MDI AS A BACKUP INSULIN THERAPY. CALLER WAS ALSO ADVISED TO PLACE THE DEFECTIVE PUMP INTO STORAGE MODE BEFORE RETURNING IT WITH A PRE-PAID LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2611261 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