BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16629882 · Received March 28, 2023

    Report

    Report Number
    3013756811-2023-42630
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    January 6, 2023
    Report Date
    March 28, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 200-598 MG/DL. ELEVATED BLOOD GLUCOSE LEVELS WERE ADDRESSED BY CHANGING THE INFUSION SET AND DELIVERING A CORRECTION BOLUS VIA THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427145 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0740144 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other INFUSION SET: AUTOSOFT XCINSULIN: HUMALOG