BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22968452 · Received September 4, 2025

    Report

    Report Number
    3013756811-2025-208750
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 4, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152286716
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CALLER REPORTED THAT A PUMP MALFUNCTION OCCURRED AFTER THE PUMP GOT WET A WEEK AGO. BLOOD GLUCOSE LEVEL DID NOT EXCEED 500 MG/DL AND THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT ASSISTED THE CALLER WITH RESETTING THE PUMP, AFTER WHICH THE MALFUNCTION DID NOT RECUR, AND INSTRUCTED THE CALLER TO CONTINUE USING THE PUMP WHILE ADVISING TO CALL BAC K IF ANY ISSUE ARISES AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082358 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152286716

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female