BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11821578 · Received May 13, 2021

    Report

    Report Number
    3013756811-2021-49049
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 13, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007301
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING BOLUS INSULIN DELIVERY. REPORTEDLY, THE CARTRIDGE WAS CHANGED TO ADDRESS THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. REPORTEDLY, THE ALARM WAS CLEARED AND INSULIN DELIVERY WAS RESUMED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 240-253 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715777 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR