BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16856831 · Received May 2, 2023

    Report

    Report Number
    3013756811-2023-57288
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 11, 2023
    Report Date
    May 2, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS CRACKED AND UNREADABLE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200-225 MG/DL. THE CUSTOMER WILL CONTINUE TO USE CURRENT PUMP FOR INSULIN THERAPY OR MDI IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818012 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male