BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16444637 · Received February 27, 2023

    Report

    Report Number
    3013756811-2023-24389
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 6, 2023
    Report Date
    February 27, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED WITHIN THE INFUSION SET TUBING. CUSTOMER CHANGED THE INFUSION SET TUBING TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 243-244 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752856 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0385728

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male INSULIN: HUMALOG.INFUSION SET: TRUSTEEL.