BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 22435824 · Received July 8, 2025

    Report

    Report Number
    3013756811-2025-160335
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 8, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152407111
    PMA / PMN Number
    K232380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE LEVEL IN THE 50S MG/DL. SUSPECTED CAUSE WAS DUE TO THE CUSTOMER¿S SETTINGS REQUIRING ADJUSTMENTS. THE CUSTOMER ADDRESSED THIS LOW LEVEL BY DRINKING A MOUNTAIN DEW, AND THERE WAS NO NEED FOR THIRD-PARTY ASSISTANCE. TECHNICAL SUPPORT ASSISTED THE CUSTOMER IN UPDATING THE CORRECTION FACTOR SETTING AND ADVISED CHECKING IN WITH THEIR HEALTHCARE PROVIDER WHENEVER SETTINGS ARE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373108 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152407111

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other