BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® VIRTUO® INSTRUMENT

    MDR report key: 8102474 · Received November 26, 2018

    Report

    Report Number
    1950204-2018-00579
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Report Date
    February 3, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MDB
    UDI-DI
    03573026369767
    PMA / PMN Number
    K161816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CONNECTION ANOMALY BETWEEN THE BACT/ALERT® VIRTUO® INSTRUMENT (REFERENCE 411660) AND THE MYLA® SERVER. A REVIEW OF THE INSTRUMENT/SOFTWARE LOGS SHOWED THE PROBLEM WAS DUE TO A NETWORK CONFIGURATION CHANGE SPECIFIC TO ONE VIRTUO AT THE CUSTOMER SITE. THIS CHANGE HAD BROKEN THE TIME SERVER CONNECTION OF VIRTUO, SO THE VIRTUO COMPUTER DID NOT HAVE THE TIME SYNCHRONIZED WITH OTHER SYSTEMS AND MYLA. AFTER A PERIOD OF TIME (WEEK/MONTH), THIS VIRTUO TIME DRIFTED TO MORE THAN 40 SECONDS (LIMIT ACCEPTABLE IN MYLA), SO MYLA RAISED THE CONNECTION STATUS TO RED, WHICH STOPS GENERATING AND SENDING NTD MESSAGE TO THE CUSTOMER'S LIS. MYLA WORKED AS EXPECTED AS THE SUPERVISION SCREEN WARNS THE USER BY DISPLAYING A RED VIRTUO CONNECTION STATUS. ON 31OCT2018 11:44:37, THE NTP (TIME SERVER) WAS CORRECTLY RECONFIGURED ON THE VIRTUO BY THE LOCAL FIELD APPLICATION SPECIALIST. THE TIME SYNCHRONIZATION BETWEEN MYLA AND VIRTUO IS A KEY POINT HIGHLIGHTED IN BOTH THE MYLA AND VIRTUO SERVICE MANUALS: "4.9.2.3 CONFIGURE TIME SERVER BETWEEN VIRTUO AND MYLA" IN "MYLA SERVICE MANUAL" [4501-2129-N1] (VERSION APPLICABLE TO MYLA 4.5) "4.2.1.3 SYNCHRONIZING MYLA AND VIRTUO CLOCKS" [514738-5EN1_-_2017-07] (VERSION APPLICABLE TO VIRTUO R2) THE TROUBLESHOOTING IS IDENTIFIED IN THE SERVICE MANUAL IN "8.2 ERRORS AND TROUBLESHOOTING" IN THE "VIRTUO" SECTION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A CONNECTION ANOMALY BETWEEN THE BACT/ALERT® VIRTUO® INSTRUMENT (REFERENCE (B)(4)) AND THE MYLA® SERVER. THE CUSTOMER REPORTED THIS ANOMALY WAS LIKELY DUE TO THE DAYLIGHT SAVINGS TIME CHANGE. NO RESULTS WERE SENT BETWEEN VIRTUO AND MYLA. THERE WAS A DELAY IN NEGATIVE-TO-DATE RESULTS AFTER 36 HOURS. THERE WERE 38 MESSAGES AND THREE (3) PEDIATRIC PATIENTS. THE IMPACT OF THE NEGATIVE TO DATE MESSAGES IS STILL UNDER INVESTIGATION BY THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941351 BACT/ALERT® VIRTUO® INSTRUMENT BACT/ALERT® VIRTUO® INSTRUMENT MDB BIOMERIEUX, INC. 411660 03573026369767

    Patients

    Seq Age Sex Outcome Treatment
    1