BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 23101198 · Received September 19, 2025

    Report

    Report Number
    3013756811-2025-220778
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    September 1, 2023
    Report Date
    January 13, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CALLER REPORTED DAMAGE TO THE PUMP HOUSING AND USB PORT, WHICH IMPACTED THE ABILITY TO CHARGE THE PUMP AND LED TO A SHUTDOWN. THE ISSUE RESULTED IN HOSPITALIZATION AND ADMISSION TO THE INTENSIVE CARE UNIT (ICU), WITH THE BLOOD GLUCOSE LEVEL REACHING BETWEEN 800-899 MG/DL, WHICH WAS CLASSIFIED AS DANGEROUS DUE TO KETONE PRESENCE. TREATMENT WITH INTRAVENOUS SALINE AND INSULIN RESOLVED THE ISSUE, AND THERE WAS NO PERMANENT DAMAGE REPORTED. CUSTOMER WAS RELEASED FROM THE HOSPITAL ON APRIL 8, 2025, AND A REPLACEMENT PUMP WAS SENT BY TECHNICAL SUPPORT. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722543 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other