BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2, BASAL-IQ, MMOL/L

    MDR report key: 10062286 · Received May 15, 2020

    Report

    Report Number
    3013756811-2020-50552
    Event Type
    Malfunction
    Date Received
    May 15, 2020
    Date of Event
    April 21, 2020
    Report Date
    May 15, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED AN OCCLUSION OCCURRED. THE CUSTOMER¿S BLOOD GLUCOSE WAS 252-253 MG/DL. THE CUSTOMER CHANGED ALL SUPPLIES AND RESUMED INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524458 T:SLIM X2, BASAL-IQ, MMOL/L AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR INSULIN: NOVOLOG/NOVORAPID, INFUSION SET: AUTOSOFT