BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15485429 · Received September 26, 2022

    Report

    Report Number
    3013756811-2022-101864
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    August 24, 2022
    Report Date
    August 31, 2022
    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 · 0

    DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. A SYSTEM CHECK WAS PERFORMED, AND THE PUMP PERFORMED AS INTENDED. CUSTOMER SUCCESSFULLY RESUMED INSULIN DELIVERIES AFTER THE SYSTEM CHECK. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 251-253 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604260 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female INFUSION SET: TRUSTEEL, INSULIN: NOVOLOG/NOVORAPID