BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15709401 · Received November 1, 2022

    Report

    Report Number
    3013756811-2022-119784
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    October 9, 2022
    Report Date
    November 1, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE CUSTOMER WAS EXPERIENCING INTERMITTENT ELEVATED BLOOD GLUCOSE (BG) LEVELS BETWEEN 212-338 MG/DL; CAUSE WAS NOT KNOWN. REPORTEDLY, DUE TO THE ELEVATED BG LEVELS, THE CUSTOMER EXPERIENCED NAUSEA AND VOMITING. CUSTOMER ADMINISTERED A CORRECTION BOLUS VIA THE PUMP TO ADDRESS THE BG. TANDEM TECHNICAL SUPPORT PERFORMED A FULL PUMP SYSTEM CHECK AND VERIFIED THAT PUMP WAS OPERATING APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059467 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other INSULIN: NOVOLOG