BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS

    MDR report key: 6653215 · Received June 20, 2017

    Report

    Report Number
    3002769706-2017-00139
    Event Type
    Malfunction
    Date Received
    June 20, 2017
    Report Date
    October 4, 2017
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    PMA / PMN Number
    DEN130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION IN ASSOCIATION WITH THE VITEK® MS. THE CUSTOMER STATED A SAMPLE WAS TESTED SEVERAL TIMES AND THE VITEK® MS GAVE TWO DIFFERENT IDENTIFICATIONS AS SINGLE CHOICE FOR THE SAME STRAIN. ONCE AS SINGLE CHOICE : STAPHYLOCOCCUS WARNERI. TWICE AS SINGLE CHOICE: PREVOTELLA BUCCALIS. LOW DISCRIMINATION: STAPHYLOCOCCUS.WARNERI - PREVOTELLA.BUCCALIS THE CUSTOMER DID NOT USE AN ALTERNATIVE METHOD FOR IDENTIFICATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED, WHICH INCLUDED ANALYSIS OF THE DATA LOGS SUBMITTED BY THE CUSTOMER. CONCLUSION ON THE SYSTEM: SYSTEM OPERATIONAL DURING THE TEST ON (B)(6) 2017. SYSTEM NEAR THE LIMIT DURING THE TEST ON (B)(6) 2017. CONCLUSION ON THE IDENTIFICATION: REGARDING THE CUSTOMER DATA, THE MOST PROBABLE IDENTIFICATION IS STAPHYLOCOCCUS WARNERI. PREVOTELLA GENUS SPECTRA COMPOSITION IS DIFFERENT BETWEEN KNOWLEDGE BASE (KB) (B)(4) AND KB (B)(4). THERE ARE MORE SPECIES IN KB (B)(4) FROM THIS GENUS. WITH THESE MODIFICATIONS AND SPECTRA ADDITIONS, THE KB (B)(4) MODEL CAN MORE EASILY IDENTIFY PREVOTELLA GENUS ISOLATES, AND ALSO EXCLUDE THIS IDENTIFICATION WHEN THE ISOLATE IS NOT PREVOTELLA GENUS. SPECTRA SIMILARITY WITH INTERNAL SPECTRA: THE COMPARISON BETWEEN CUSTOMER SPECTRA AND INTERNAL SPECTRA SHOWS THAT CUSTOMER SPECTRA ARE CLEARLY CLOSER TO STAPHYLOCOCCUS WARNERI THAN THE OTHER SPECIES. THERE IS AROUND 65% OF SIMILARITY. SUSPECTED ROOT CAUSE OF THE ISSUE: VITEK® MS SYSTEM LIMITATION: ROBUSTNESS OF PREVOTELLA BUCCALIS CLASS AND GLOBALLY PREVOTELLA GENUS CLASSES. NON-OPTIMAL SPOT PREPARATION. CORRECTED DATA: THE VITEK® MS INSTRUMENT MANUFACTURING ADDRESS AND 510K NUMBER HAVE BEEN UPDATED.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE (B)(4) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION IN ASSOCIATION WITH THE VITEK® MS. THE CUSTOMER STATED A SAMPLE WAS TESTED SEVERAL TIMES AND THE VITEK® MS GAVE TWO DIFFERENT IDENTIFICATIONS AS SINGLE CHOICE FOR THE SAME STRAIN. ONCE AS SINGLE CHOICE : STAPHYLOCOCCUS WARNERI. TWICE AS SINGLE CHOICE: PREVOTELLA BUCCALIS. LOW DISCRIMINATION: STAPHYLOCOCCUS.WARNERI - PREVOTELLA.BUCCALIS. THE CUSTOMER DID NOT USE AN ALTERNATIVE METHOD FOR IDENTIFICATION. IT IS NOT KNOWN IF A RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433580 VITEK® MS VITEK® MS PEX BIOMERIEUX, SA 410895

    Patients

    Seq Age Sex Outcome Treatment
    1