BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11339299 · Received February 17, 2021

    Report

    Report Number
    3013756811-2021-19792
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 24, 2021
    Report Date
    February 17, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARTRIDGE INTERMITTENTLY DID NOT FIT ONTO THE PUMP. REPORTEDLY, THERE WERE MULTIPLE O-RINGS FROM PREVIOUS CARTRIDGES ON THE PNEUMATIC TAP. THE CUSTOMER REMOVED THE O-RINGS AND RELOADED CARTRIDGE TO ADDRESS THE EVENT. BLOOD GLUCOSE LEVEL RANGED FROM 120-152 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236205 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1