BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMMANDER

    MDR report key: 5596048 · Received April 21, 2016

    Report

    Report Number
    3005853093-2016-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2016
    Date of Event
    March 12, 2016
    Report Date
    April 21, 2016
    Manufacturer
    GLYTEC, LLC
    Product Code
    NDC
    PMA / PMN Number
    K113853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS LATE DUE TO DIFFICULTIES AND DELAYS GETTING THE EMDR SYSTEM SET UP AND REGISTERED.

    Description of Event or Problem · 1

    GLYTEC DISCOVERED A SOFTWARE ERROR IN THE GLUCOMMANDER APPLICATION THAT AFFECTED TIME PROCESSING IN THE HOURS PRIOR TO THE CHANGE FROM STANDARD TIME TO DAYLIGHT SAVINGS TIME. THE ERROR CORRECTED AFTER 2AM LOCAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249722 GLUCOMMANDER PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR NDC GLYTEC, LLC 3.1

    Patients

    Seq Age Sex Outcome Treatment
    1