BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS

    MDR report key: 5201947 · Received November 4, 2015

    Report

    Report Number
    3002769706-2015-00138
    Event Type
    Malfunction
    Date Received
    November 4, 2015
    Report Date
    September 29, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    PEX
    PMA / PMN Number
    K124067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. A BIOMERIEUX FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE AND PERFORMED A FINE-TUNING PROCEDURE IN ORDER TO OBTAIN RESULTS FOR MASSES OF 10,000 - 13,000 DA. FOLLOWING FINE-TUNING, THE CUSTOMER RETESTED SPECIMENS AND RECEIVED VERY GOOD RESULTS, INDICATING THE FINE-TUNING PROCEDURE RESOLVED THE ISSUE. SYSTEM LOGS WERE REVIEWED AND CONFIRMED NO OTHER ISSUES WERE PRESENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BIOMERIEUX THAT THEIR VITEK 2 MS SYSTEM IS NOT PROVIDING IDENTIFICATIONS FOR STREPTOCOCCUS OR YEASTS. ALL OTHER ORGANISM TYPES ARE REPORTING AS EXPECTED. THE CUSTOMER INDICATES A DELAY >24 HOURS TO REPORT RESULTS TO THE PHYSICIAN. THE CUSTOMER INDICATED TO BIOMERIEUX THAT THE DELAY HAS NOT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED. FOLLOWING THE REPORTED EVENT, A BIOMERIEUX FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE REGARDING THE REPORTED ISSUE. A FINE-TUNING PROCEDURE WAS PERFORMED IN ORDER TO OBTAIN RESULTS FOR MASSES OF 10,000 - 13,000 DA. FOLLOWING FINE-TUNING, THE CUSTOMER RETESTED SPECIMENS AND RECEIVED VERY GOOD RESULTS, INDICATING THE FINE-TUNING PROCEDURE RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731160 VITEK MS VITEK MASS SPECTROMETER PEX BIOMERIEUX SA

    Patients

    Seq Age Sex Outcome Treatment
    1