BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16094201 · Received January 4, 2023

    Report

    Report Number
    3013756811-2023-00795
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 4, 2022
    Report Date
    January 4, 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. DEVICE NOT RETURNED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONTROL IQ SOFTWARE DID NOT ADJUST 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. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 251-253 MG/DL. A PUMP RESET WAS PERFORMED TO ADDRESS THE ISSUE. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178273 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 Male