BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17869144 · Received October 4, 2023

    Report

    Report Number
    3013756811-2023-140699
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 12, 2023
    Report Date
    October 4, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE TANDEM PUMP USER GUIDE INSTRUCTS THE USER TO REMOVE ANY RESIDUAL AIR FROM THE CARTRIDGE. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INTERMITTENT INACCURATE. REPORTEDLY, THE CUSTOMER WAS NOT REMOVING THE AIR FROM THEIR CARTRIDGE DURING THE LOADING SEQUENCE. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 123 - 175 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116963 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male