BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 25173699 · Received May 14, 2026

    Report

    Report Number
    3013756811-2026-87368
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    May 10, 2026
    Report Date
    May 14, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319612
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL DISPLAYED AS ¿LOW¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. REPORTEDLY THE CUSTOMERS WEIGHT WAS PROGRAMMED INCORRECTLY. REPORTEDLY THE CUSTOMER REQUIRED ASSISTANCE AND WAS GIVEN CARBOHYDRATES BY EMERGENCY MEDICAL SERVICES TO ADDRESS BG. TANDEM TECHNICAL SUPPORT EDUCATED CALLER ABOUT CONTROL IQ TECHNOLOGY AND THE ALGORITHM USING WEIGHT INFORMATION TO ADJUST INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466464 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152319612

    Patients

    Seq Age Sex Outcome Treatment
    1