BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12447318 · Received September 9, 2021

    Report

    Report Number
    3013756811-2021-97724
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    August 25, 2021
    Report Date
    September 9, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007998
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENTLY CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE (BG 122-450 MG/DL) AND CUSTOMER VOMITED A FEW TIMES. CUSTOMER DELIVERED A CORRECTION BOLUS TO ADDRESS BG AND THE INFUSION SET WAS CHANGED. PUMP SYSTEM CHECK WAS PERFORMED AND NO DEVICE ISSUES WERE IDENTIFIED. CONTACT WAS ADVISED TO DISCUSS EVENT WITH THEIR HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345214 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007998

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INSULIN: NOVORAPID, INFUSION SET: AUTOSOFT 90