BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16093971 · Received January 4, 2023

    Report

    Report Number
    3013756811-2023-00084
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 15, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 251-271 MG/DL. PRIOR TO THE REPORT WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CHANGED THE CARTRIDGE AND THE INFUSION SET, THEREFORE, NO TROUBLESHOOTING COULD BE PERFORMED TO DETERMINE A ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419440 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0061901

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female INSULIN: NOVOLOG/NOVOLOG RAPID.INFUSION SET: TRUST.