BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15607085 · Received October 14, 2022

    Report

    Report Number
    3013756811-2022-110030
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Date of Event
    September 22, 2022
    Report Date
    October 14, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 210-211 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888445 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0459533

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male