BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22466809 · Received July 10, 2025

    Report

    Report Number
    3013756811-2025-163348
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 12, 2025
    Report Date
    July 10, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000107
    PMA / PMN Number
    K203234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CONTROL-IQ (CIQ) WAS NOT ADJUSTING INSULIN DELIVERY AS EXPECTED. TROUBLE SHOOTING WITH TANDEM TECHNICAL SUPPORT (TTS) DETERMINED THAT THE CUSTOMER HAD CIQ TURNED OFF. TTS EDUCATED THE CUSTOMER THAT CIQ MUST BE TURNED ON TO ADJUST BASAL DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 46 MG/DL. THE CUSTOMER CONSUMED GLUCOSE TABLETS TO ADDRESS THE LOW BLOOD GLUCOSE LEVEL AND LOST CONSCIOUSNESS TEMPORARILY AFTER THEY TREATED THEIR DECREASED BG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316485 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152000107

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Life Threatening| O