BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMMANDER

    MDR report key: 5967144 · Received September 21, 2016

    Report

    Report Number
    3005853093-2016-00002
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    August 24, 2016
    Report Date
    September 21, 2016
    Manufacturer
    GLYTEC, LLC
    Product Code
    BTY
    UDI-DI
    00860057000305
    PMA / PMN Number
    K113853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    GLYTEC DISCOVERED A SOFTWARE ERROR IN THE GLUCOMMANDER APPLICATION THAT AFFECTED BASAL DOSING RECOMMENDATIONS WHEN EDITED USING TWICE DAILY DOSING. AFTER THE EDIT IS PERFORMED THE BASAL DOSE RECOMMENDATION ADJUSTS INCORRECTLY. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619285 GLUCOMMANDER PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR BTY GLYTEC, LLC 3.2 00860057000305

    Patients

    Seq Age Sex Outcome Treatment
    1