BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15485018 · Received September 26, 2022

    Report

    Report Number
    3013756811-2022-103120
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    August 31, 2022
    Report Date
    August 31, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 210-215 MG/DL. A SYSTEMS CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND NO ISSUES WERE IDENTIFIED. THE CUSTOMER SUCCESSFULLY CHANGED SUPPLIES AND RESUMED INSULIN DELIVERY AFTER THE SYSTEMS CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2931454 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 67 YR Female INFUSION SET: AUTOSOFT XC INSULIN: HUMALOG