BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15758633 · Received November 9, 2022

    Report

    Report Number
    3013756811-2022-123019
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 20, 2022
    Report Date
    November 9, 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

    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 MULTIPLE OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 251-271 MG/DL. REPORTEDLY, THE CUSTOMER CHANGED THE INFUSION SET AND ALARM REOCCURRED. SUBSEQUENTLY, THE CUSTOMER CLEARED THE ALARM AND RESUMED INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432054 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 35 YR Female INSULIN: NOVOLOG/NOVOLOG RAPIDINFUSION SET: AUTOS