BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22398970 · Received July 3, 2025

    Report

    Report Number
    3013756811-2025-158268
    Event Type
    Injury
    Date Received
    July 3, 2025
    Date of Event
    June 13, 2025
    Report Date
    July 3, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED A PAST LOW BLOOD GLUCOSE (BG) LEVEL (2.9 MMOL/L). NO ACTION WAS TAKEN TO ADDRESS THE BG LEVEL. THE CAUSE FOR THE LOW BG IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934867 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other