BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16292577 · Received February 3, 2023

    Report

    Report Number
    3013756811-2023-16373
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 9, 2023
    Report Date
    February 3, 2023
    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

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONTROL IQ SOFTWARE IS NOT ADJUSTING INSULIN DELIVERY AS INTENDED. REPORTEDLY, INSULIN WAS BEING DELIVERED BASED OFF THE PUMP PERSONAL PROFILE SETTINGS INSTEAD OF CONTROL IQ SETTINGS DESPITE CONTROL IQ BEING TURNED ON. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. ADDITIONAL INFORMATION WAS NOT PROVIDED. MULTIPLE ATTEMPTS WERE MADE BY TANDEM¿S TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, A RESPONSE FROM THE CUSTOMER WAS NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769675 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 56 YR Male INSULIN: HUMALOGINFUSION SET: AUTOSOFT 90