BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMMANDER

    MDR report key: 7163932 · Received January 4, 2018

    Report

    Report Number
    3005853093-2018-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 8, 2017
    Report Date
    January 4, 2018
    Manufacturer
    GLYTEC, LLC
    Product Code
    NDC
    UDI-DI
    00860057000305
    PMA / PMN Number
    K113853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PATCH WAS CREATED IN VERSION 3.3.4.5, WHICH WAS RELEASED JANUARY 3, 2018. THE EFFECTED CLIENTS WILL BE UPGRADED AS SOON AS POSSIBLE.

    Description of Event or Problem · 1

    AFTER A SPLIT TRANSITION, EDITING THE ORDER SET RENDERS A FULL DOSE INSTEAD OF SECOND HALF OF SPLIT DOSE AT NEXT BASAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9556 GLUCOMMANDER PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR NDC GLYTEC, LLC 3.3.2.0 00860057000305

    Patients

    Seq Age Sex Outcome Treatment
    1