BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMMANDER

    MDR report key: 8293927 · Received January 31, 2019

    Report

    Report Number
    3005853093-2019-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2019
    Date of Event
    January 10, 2019
    Report Date
    January 31, 2019
    Manufacturer
    GLYTEC, LLC.
    Product Code
    NDC
    UDI-DI
    00860057000305
    PMA / PMN Number
    K113853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PATCH WAS CREATED IN VERSION 3.4.3.2 WHICH WAS RELEASE JANUARY 12, 2019. ALL EFFECTED CLIENTS WERE UPGRADE BY JANUARY 31, 2019.

    Description of Event or Problem · 1

    GLUCOMMANDER INTEGRATION WITH THE ELECTRONIC MEDICAL RECORD (EMR) MAY CAUSE INCORRECT PATIENT TO LOAD. ON VERY RARE INSTANCES, A SYSTEM ERROR MAY CAUSE SMARTCLICK REQUESTS TO OVERLAP AND IDENTIFY THE WRONG PATIENT FOR A TREATMENT REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88198 GLUCOMMANDER PREDICTIVE PULMONARY FUNCTION NDC GLYTEC, LLC. 3.4.1.0 00860057000305

    Patients

    Seq Age Sex Outcome Treatment
    1