BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14311259 · Received May 6, 2022

    Report

    Report Number
    3013756811-2022-43061
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 14, 2022
    Report Date
    April 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 A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. SUBSEQUENTLY, THE PUMP DATE WAS INCORRECT. TANDEM TECHNICAL SUPPORT ASSISTED CUSTOMER IN CORRECTING THE PUMP DATE AND CUSTOMER RESUMED INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 182-230 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253146 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 42 YR Male