BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22816205 · Received August 15, 2025

    Report

    Report Number
    3013756811-2025-193528
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 15, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319513
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM ON (B)(6) 2025 AND WAS LATER ADMITTED TO THE INTENSIVE CARE UNIT WITH AN ELEVATED BLOOD GLUCOSE LEVEL OF 900-994 MG/DL. ELEVATED BLOOD GLUCOSE LEVEL CAUSED CUSTOMER TO HAVE MULTIPLE SEIZURES, LOSE CONSCIOUSNESS, AND HAVE A HEART ATTACK. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. CUSTOMER WAS DISCHARGED ON (B)(6) 2025 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239850 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152319513

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention| L| H NOVOLOG / NOVORAPID - INSULIN.