BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS INSTRUMENT

    MDR report key: 5725552 · Received June 15, 2016

    Report

    Report Number
    3002769706-2016-00100
    Event Type
    Malfunction
    Date Received
    June 15, 2016
    Report Date
    June 13, 2016
    Manufacturer
    BIOMERIEUX, S.A.
    Product Code
    PEX
    PMA / PMN Number
    K124067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN SWITZERLAND REPORTED A MISIDENTIFICATION OF BURKHOLDERIA MULTIVORANS AS BURKHOLDERIA CEPACIA IN ASSOCIATION WITH THE VITEK® MS SYSTEM. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE CUSTOMER PROVIDED 16S SEQUENCING RESULTS FOR FOUR SUBMITTED ISOLATES (A210449, A210450, A210451, A210452). THOUGH THE ISOLATES ARE FROM FOUR DIFFERENT LOCATIONS AT THE CUSTOMER SITE, THEY APPEAR TO BE THE SAME STRAIN. SUBMITTED LOG FILES WERE REVIEWED. ALL CALIBRATION CRITERIA ARE WITHIN THE REQUIRED THRESHOLDS; THE VITEK® MS SYSTEM IS FINE-TUNED APPROPRIATELY. THE LOG FILES FOR THE SUBMITTED ISOLATES WERE ANALYZED/SIMULATED WITH THE CLI 2.0 KNOWLEDGE BASE, CLI 3.0 KNOWLEDGE BASE, AND THE IND 3.1 KNOWLEDGE BASE. · CLI 2.0 ANALYSIS (CUSTOMER KNOWLEDGE BASE): OBTAINED SINGLE CHOICE IDENTIFICATION OF BURKHOLDERIA CEPACIA OR NO IDENTIFICATION (NOID). · CLI 3.0 ANALYSIS: OBTAINED SINGLE CHOICE IDENTIFICATION OF BURKHOLDERIA CONTAMINANS OR NOID. · IND 3.1 ANALYSIS: OBTAINED SINGLE CHOICE IDENTIFICATION OF BURKHOLDERIA CONTAMINANS OR NOID. · < MASS ANALYSIS > · FOR EACH OF THE ISOLATES TESTED, ALL OF THE SPECTRA INDICATE GOOD INTENSITY AS WELL AS HIGH MASS PEAKS. INTERNAL QUALITY CONTROL (FIVE SPOTS TESTED VIA VITEK® MS SLIDE) WAS PERFORMED FOR THE FOUR SUBMITTED STRAINS. THE MAJORITY OF THE RESULTS OBTAINED WERE NOID, WITH LIMITED IDENTIFICATION OF BURKHOLDERIA CEPACIA. THE SUBMITTED STRAINS ARE NOT VIABLE FOR TESTING VIA SEQUENCING METHODS AS THE STRAINS WERE UNABLE TO BE CULTIVATED AGAIN AFTER DEFROSTING. THE 16S METHOD PERFORMED BY THE CUSTOMER IS NOT THE MOST APPROPRIATE METHOD FOR THESE STRAINS. SEQUENCING OF THE RECA GENUS IS KNOWN TO BE BETTER TO DISTINGUISH BURKOLDERIA SPECIES. BASED ON THE INVESTIGATION RESULTS, THE STRAIN WAS IDENTIFIED AS BURKHOLDERIA CONTAMINANS. BURKHOLDERIA CONTAMINANS IS NOT IN THE VITEK® MS V2.0 KNOWLEDGE BASE, WHICH IS WHY THE RESULTS WITH KNOWLEDGE BASE V2.0 ARE NOID OR BURKHOLDERIA CEPACIA (WHICH IS THE CLOSER BURKHOLDERIA SPECIES WITHIN KB V2.0). VITEK® MS SYSTEM IDENTIFICATION IS BASED ON A COMPARISON BETWEEN SPECTRA ACQUIRED AND SPECIES PATTERN AVAILABLE IN THE KNOWLEDGE BASE. IF THE STRAIN TESTED IS NOT IN THE KNOWLEDGE BASE, NO SPECIES PATTERN WILL BE AVAILABLE FOR COMPARISON. CONSEQUENTLY, THE SYSTEM CAN GIVE NOID OR AS THE SYSTEM IS LOOKING FOR THE NEAREST SPECIES PATTERN, IT CAN ALSO GIVE A LOW DISCRIMINATION RESULT OR AN INCORRECT IDENTIFICATION (OFTEN TO THE SAME GENUS LEVEL).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A MISIDENTIFICATION ASSOCIATED WITH VITEK MS INSTRUMENT (REFERENCE 410895). THE CUSTOMER REPORTED A STRAIN WAS IDENTIFIED AS BURKHOLDERIA CEPACIA BY VITEK&#59405;MS BUT WITH THEIR MICROSEQ 16S SEQUENCING, THE STRAIN WAS IDENTIFIED AS BURKHOLDERIA MULTIVORANS 99.8%. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379872 VITEK® MS INSTRUMENT VITEK® MS INSTRUMENT PEX BIOMERIEUX, S.A. 50180

    Patients

    Seq Age Sex Outcome Treatment
    1