BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11784417 · Received May 6, 2021

    Report

    Report Number
    3013756811-2021-48867
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 6, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS NOT ABLE TO ADJUST THE TIME BELOW A CERTAIN NUMBER FOR AN EXTENDED BOLUS. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 250-259 MG/DL. REPORTEDLY, THE ISSUE WAS RESOLVED PRIOR TO CONTACTING TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683485 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR