BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMMANDER

    MDR report key: 6884024 · Received September 21, 2017

    Report

    Report Number
    3005853093-2017-00002
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 28, 2017
    Report Date
    September 21, 2017
    Manufacturer
    GLYTEC, LLC.
    Product Code
    NDC
    UDI-DI
    0086005700305
    PMA / PMN Number
    K113853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PATCH WAS CREATED IN VERSIONS 3.3.4.3 AND 3.3.1.9, WHICH WERE RELEASED (B)(6) 2017. THE EFFECTED CLIENTS WILL BE UPGRADED AS SOON AS POSSIBLE.

    Description of Event or Problem · 1

    BASAL DOSE CHARTED IN FUTURE; ADMINISTERED BASAL DOSE, ON AN INTERMITTENT RARE OCCASION CAN BE RECORDED FOR THE CORRECT DAY AND MONTH, BUT FOR YEAR 2020 INSTEAD OF YEAR DOSE WAS GIVEN. AFTER FUTURE ENTRY NO BASAL DOSE IS CALCULATED. THERE IS NO EVIDENCE OF ADVERSE EVENTS RESULTING FROM THIS BUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663438 GLUCOMMANDER PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR NDC GLYTEC, LLC. 3.3.1.5 0086005700305

    Patients

    Seq Age Sex Outcome Treatment
    1