BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMMANDER

    MDR report key: 7070153 · Received November 30, 2017

    Report

    Report Number
    3005853093-2017-00003
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 7, 2017
    Report Date
    November 30, 2017
    Manufacturer
    GLYTEC, LLC
    Product Code
    NDC
    UDI-DI
    00860057000305
    PMA / PMN Number
    K113853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PATCH WAS CREATED IN VERSION 3.3.4.4 WHICH WAS RELEASED NOVEMBER 10, 2017. THE EFFECTED CLIENTS WILL BE UPGRADED AS SOON AS POSSIBLE.

    Description of Event or Problem · 1

    AFTER TRANSITION, TRANSITION BASAL DOSE MAY NOT BE ACCOUNTED FOR - PATIENT TRANSITIONING FROM IV TO SUBQ TREATMENT RECEIVES TRANSITIONAL BASAL DOSE VIA "GIVE NOW" SELECTION. AT START OF SUBQ TREATMENT, PROMPT MAY BE PROVIDED TO GIVE FULL BASAL AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851209 GLUCOMMANDER PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR NDC GLYTEC, LLC 3.3.2.0 00860057000305

    Patients

    Seq Age Sex Outcome Treatment
    1