BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13523772 · Received February 14, 2022

    Report

    Report Number
    3013756811-2022-13199
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    January 30, 2022
    Report Date
    February 14, 2022
    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

    DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED IN THE INFUSION SET TUBING. REPORTEDLY, THE CUSTOMER LOADED CARTRIDGES WITH COLD INSULIN. TANDEM TECHNICAL SUPPORT (CTS) EDUCATED THE CUSTOMER REGARDING CARTRIDGE/INSULIN LABELING. CTS GUIDED THE CUSTOMER THROUGH PRIMING THE AIR BUBBLES OUT. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 232-233 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110664 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male INFUSION SET: VARISOFT, INSULIN: NOVOLOG