BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17038130 · Received June 1, 2023

    Report

    Report Number
    3013756811-2023-72784
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    May 10, 2023
    Report Date
    June 30, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D2B.

    Additional Manufacturer Narrative · 0

    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 AN OCCLUSION ALARM OCCURRED. A SYSTEM CHECK WAS PERFORMED BY TANDEM TECHNICAL SUPPORT AND THE OCCLUSION WAS FOUND TO BE WITHIN THE CARTRIDGE. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE OCCLUSION. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 243-343 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829676 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLE INFUSION PUMP QFG TANDEM DIABETES CARE 1000354
    419286 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLE INFUSION PUMP QFG TANDEM DIABETES CARE 1000354

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female INSULIN: NOVOLOG/NOVORAPID