BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22976052 · Received September 5, 2025

    Report

    Report Number
    3013756811-2025-209205
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 5, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319810
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A MALFUNCTION WAS REPORTED ON THE PUMP. THE CUSTOMER WENT TO THE HOSPITAL AND WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH A BLOOD GLUCOSE LEVEL OF 800-900 MG/DL AND KETONES. THE CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. TREATMENT RESOLVED THE ISSUE AND THERE WAS NO PERMANENT DAMAGE. THE CUSTOMER WAS DISCHARGED FROM THE ICU ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320985 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152319810

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Hospitalization| R