BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18918169 · Received March 15, 2024

    Report

    Report Number
    3013756811-2024-38974
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 19, 2024
    Report Date
    March 15, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007301
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP SOFTWARE DID NOT ACCURATELY ADJUST THE AMOUNT OF INSULIN DELIVERED. CUSTOMER'S BLOOD GLUCOSE WAS 250-350 MG/DL. REPORTEDLY, A PUMP RESET WAS PERFORMED TO ADDRESS THE EVENT AND THE CUSTOMER CONTINUED TO USE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320406 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female