BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12698628 · Received October 26, 2021

    Report

    Report Number
    3013756811-2021-111678
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    October 2, 2021
    Report Date
    October 26, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP RESET UNEXPECTEDLY. REPORTEDLY, THE CARTRIDGE WAS CHANGED TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS RESUMED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 251-271 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595825 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 M841762

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR INFUSION SET: TRUSTEEL, INSULIN: NOVOLOG