BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 10648855 · Received October 8, 2020

    Report

    Report Number
    9615754-2020-00157
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Report Date
    October 8, 2020
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO THE CUSTOMER COMPLAINT, BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION. REVIEW OF THE CUSTOMER¿S DATA SHOWED THE FINE-TUNING OF THE VITEK® MS INSTRUMENT WAS NOT OPTIMAL AT THE TIME OF THE ORGANISM MISIDENTIFICATION. THE REVIEW ALSO FOUND THE CUSTOMER¿S SPOT PREPARATION QUALITY WAS NOT OPTIMAL; THE SAMPLE ¿ALL PEAKS¿ VALUES WERE QUITE HETEROGENEOUS. ANALYSIS OF THE MZML SAMPLE SHOW THAT THE MISIDENTIFICATION RESULT OF BRUCELLA SPP. WAS OBTAINED FROM THE SPECTRA HAVING THE LOWEST NUMBER OF PEAKS (30) WHICH IS THE ACCEPTABLE LIMIT FOR GIVING AN ¿IDENTIFICATION¿ RESULT RATHER THAN A ¿NO IDENTIFICATION¿ RESULT. THIS COULD BE CAUSED BY THE NON-OPTIMAL SPOT PREPARATION OF THE SAMPLE STRAIN AND BY NON-OPTIMAL FINE-TUNING. BIOMÉRIEUX PERFORMED A FINE-TUNING ON THE CUSTOMER¿S VITEK® MS AND PROVIDED THE CUSTOMER WITH SPOT PREPARATION TRAINING MATERIALS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS IN ASSOCIATION WITH THE VITEK®MS INSTRUMENT (REF. 410895, SERIAL NUMBER (B)(4)) AND KNOWLEDGE BASE (KB) VERSION (B)(4) WHEN TESTING ATCC® 43300¿ STAPHYLOCOCCUS AUREUS. THE CUSTOMER CULTURED ATCC® 43300¿ STAPHYLOCOCCUS AUREUS USING OXOID COLUMBIA BLOOD AGAR, THE CULTURE WAS THEN INCUBATED FOR TWENTY-FOUR (24) HOURS PRIOR TO TESTING ON THE VITEK® MS INSTRUMENT. THE CUSTOMER THEN TESTED THE ATCC® 43300¿ STAPHYLOCOCCUS AUREUS ISOLATE ON VITEK MS INSTRUMENT; AN IDENTIFICATION OF BRUCELLA SP, WAS OBTAINED. THE ISOLATE WAS RETESTED EIGHT (8) TIMES. THE VITEK® MS OBTAINED A SINGLE CHOICE TO STAPHYLOCOCCUS AUREUS SIX (6) TIMES AND A NOID RESULT TWICE. ADDITIONALLY, THE MORPHOLOGY AND BIOCHEMICAL TESTS PERFORMED CORRESPONDED TO STAPHYLOCOCCUS AUREUS. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111944 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1