BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMMANDER

    MDR report key: 20526568 · Received October 24, 2024

    Report

    Report Number
    3005853093-2024-00001
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Report Date
    October 15, 2024
    Manufacturer
    GLYTEC, LLC
    Product Code
    NDC
    UDI-DI
    00860057000305
    PMA / PMN Number
    K152300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN UNCOMMON WORKFLOW IN GLUCOMMANDER SUBQ V3.5.1.2 OR LATER, E.G., DELIVERING BASAL DOSE MANY HOURS LATE AND CHANGING THE DOSE DISTRIBUTION, MAY RESULT IN A PLANNED GUARDRAIL TO NOT FUNCTION AS INTENDED RESULTING IN A HIGHER THAN EXPECTED BASAL DOSE RECOMMENDATION. THIS WAS OBSERVED TO OCCUR ONCE IN 100S OF 1000S OF BASAL DOSE RECOMMENDATIONS. THIS ISSUE WAS ADDRESSED IN SOFTWARE PATCH 3.5.2.2, RELEASED APRIL 27, 2023 AND IMPLEMENTED BY THE CUSTOMER MAY 6, 2023. THIS MDR WAS INITIALLY SUBMITTED THROUGH ESG ON 08-FEB-2023 AS "FDA MDR 08-FEB-2023 FINAL VERSION.PDF". ON 25-SEP-2024, IT CAME TO GLYTEC'S ATTENTION THAT THE EMDR HAD FAILED TO LOAD SUCCESSFULLY INTO THE CDRH ADVERSE EVENT DATABASE. HENCE, GLYTEC CONTACTED CESUB HELP DESK ON 25-SEP-2024 TO INQUIRE WHY THE SUBMISSION ON 08-FEB-2023 FAILED. CESUB HELP LOGGED GLYTEC'S INQUIRY AS CSH-36933. ON 01-OCT-2024, CESUB RESPONDED TO GLYTEC STATING: "THE SUBMITTED PDF FILE AS THE SUBMISSION FILE BUT THE SUBMISSION FILE HAS TO BE A ZIP FILE THAT'S CREATED USING ESUBMITTER. PLEASE ADVISE THE USER TO USE ESUBMITTER TO CREATE THEIR SUBMISSION." THEREFORE, GLYTEC IS GOING TO RE-SUBMIT THIS MDR VIA ESG AFTER RE-CREATING IT (THIS REPORT YOU ARE READING NOW) USING ESUBMITTER.

    Description of Event or Problem · 0

    GLYTEC RECEIVED A CALL FROM A HEALTHCARE PROFESSIONAL WHO WAS ATTEMPTING TO MODIFY A PATIENT'S RECOMMENDED BASAL DOSAGES AND DOSE FREQUENCY. UPON DOING SO, THE NEW BASAL DOSE RECOMMENDATION WAS HIGHER THAN THE NURSE EXPECTED. THIS DOSE WAS NOT ADMINISTERED TO THE PATIENT AND NO ADVERSE EVENTS NECESSITATING MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856731 GLUCOMMANDER ELECTRONIC GLYCEMIC MANAGEMENT SYSTEM (EGMS) NDC GLYTEC, LLC 3.5.1.2 00860057000305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown