BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOMMANDER, G+

    MDR report key: 2794104 · Received October 9, 2012

    Report

    Report Number
    3005853093-2012-00001
    Event Type
    Injury
    Date Received
    October 9, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 4, 2012
    Manufacturer
    GLYTEC, LLC.
    Product Code
    NDC
    PMA / PMN Number
    K101344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIVING THIS INFO, THE GLYTEC TECHNICAL SERVICES TEAM WAS DISPATCHED TO ASSIST CLIENT WITH TROUBLESHOOTING. ALL CUSTOMER OWNED HARDWARE VOLUME SETTINGS WERE SET AT SUFFICIENT HEARING LEVELS. THE NURSING STAFF INSTITUTED A BACKUP PROCEDURE FOR AUDIBLE REMINDERS. VISUAL ALARMS WERE PERFORMING WITHIN SPECIFICATION. DURING THE SITE ASSESSMENT, THE TECHNICIAN COULD NOT LOCATE ANYONE WHO OBSERVED THE ISSUE BUT DID OBSERVE THE ISSUE ON A SINGLE OCCASION AND NOTED THE APPLICATION (DEVICE) WAS HOSTED BY THE CLIENT AND NOT GLYTEC. A HOSPITAL IT TECHNICIAN ALSO MENTIONED THAT THE HOSPITAL'S WIRELESS NETWORK HAD BEEN DOWN FOR A PERIOD OF TIME IN CERTAIN LOCATIONS. TESTING OF THE HARDWARE AND SOFTWARE REVEALED THE ISSUE COULD NOT BE DEMONSTRATED USING THE SAME VERSION OF THE SOFTWARE HOSTED ON THE GLYTEC SERVER SYSTEM AND BOTH THE SOFTWARE AND THE HARDWARE WERE OPERATING WITHIN SPECIFICATION. IT WAS CONCLUDED THAT SINCE THE SOFTWARE WAS HOSTED BY THE CUSTOMER, THE CUSTOMER SERVER WAS THE LIKELY CAUSE AND WAS MODIFIED TO ELIMINATE AN INTERMITTENT SERVER/NETWORK CONFLICTS. THE INCIDENT WAS MOST LIKELY DUE TO AN INTERMITTENT CUSTOMER SERVER/NETWORK CONFLICT RESOLVED BY THE MODIFICATION AND TO DATE, NO FURTHER INCIDENTS REPORTED. NO OTHER SIMILAR INCIDENTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT THE AUDIBLE ALARM, ON THE CUSTOMER OWNED COMPUTER USED TO ACCESS THE SOFTWARE PRODUCT, DID NOT SOUND WHEN BG WAS DUE. PT EXPERIENCED A BG OF 56 MG/DL. A CCU NURSE HAPPENED TO BE WALKING BY THE ROOM AND SAW THE VISUAL "BG DUE" ALARM ON THE SCREEN. PT'S BLOOD GLUCOSE HAD DROPPED TO 56 MG/DL AND WAS SYMPTOMATIC. TREATMENT WAS GIVEN AND AN INCIDENT FROM COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMMANDER, G+ GLUCOMMANDER, G+ NDC GLYTEC, LLC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention