BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 23179573 · Received September 30, 2025

    Report

    Report Number
    3013756811-2025-226511
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 24, 2025
    Report Date
    September 30, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A MALFUNCTION ON THE PUMP AFTER IT GOT WET WHILE IN A POOL, RESULTING IN A MALFUNCTION CODE DISPLAY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL DID NOT EXCEED 500 MG/DL, INDICATING THERE WAS NO REPORT OF ADVERSE IMPACT. TECHNICAL SUPPORT DECIDED TO REPLACE THE PUMP AS IT WAS NOT FEASIBLE TO RESET THE MALFUNCTION CODE, EVEN THOUGH THE PUMP WAS NOT UNDER WARRANTY. CUSTOMER CALLED BACK PUMP IS OOW, CUSTOMER DECLINED OOW LOANER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673582 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male