BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 10880374 · Received November 20, 2020

    Report

    Report Number
    9615754-2020-00182
    Event Type
    Injury
    Date Received
    November 20, 2020
    Report Date
    January 21, 2021
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE NETHERLANDS REGARDING A MISIDENTIFICATION OF ACTINOMYCES RADINGAE AS BRUCELLA SPP WHEN TESTING A PATIENT STRAIN WITH THE VITEK® MS INSTRUMENT. THE STATUS OF THE FINE TUNING WAS AT THE OPERATIONAL LIMIT AT THE TIME OF ACQUISITION. A FINE TUNING WAS NEEDED DURING THE CUSTOMER TESTS. THE CUSTOMER¿S SPOT PREPARATION QUALITY WAS NOT OPTIMAL. THE CALIBRATOR ¿ALL PEAKS¿ VALUES WERE QUITE HETEROGENEOUS. BASED ON THE INFORMATION PROVIDED, THE EXPECTED IDENTIFICATION WAS DEFINED AS ACTINOMYCES RADINGAE GROUP, WHICH IS PRESENT IN THE VITEK® MS KNOWLEDGE BASE (KB) V3.2 USED BY THE CUSTOMER. THE MISIDENTIFICATION WAS OBTAINED AFTER A RE-SHOOT OF THE SAME SPOT. THERE WAS THE FOLLOWING ¿ACQUISITION/COMPUTATION MESSAGE¿ DISPLAYED IN MYLA FOR THE FIRST SHOOT ON THE SPOT : ¿SAMPLE SPOT - NOT ENOUGH PEAKS¿. THIS FINDING ALLOWS TO SHOW THAT THE ISSUE COULD BE LINKED TO THE SAMPLE SPOT PREPARATION. THIS HYPOTHESIS WAS REINFORCED BY THE FACT THAT THE SPOTTING WAS MADE WITH VERY SMALL GROWING COLONIES. IN THESE CONDITIONS, IT IS MORE DIFFICULT TO PERFORM THE SAMPLE SPOT PREPARATION. BY REPROCESSING THE CUSTOMER DATA WITH UPCOMING VITEK® MS KB UNDER DEVELOPMENT, BOTH SPECTRA LED TO A NO IDENTIFICATION RESULT. THERE WAS NO MISIDENTIFICATION. CONSEQUENTLY, THE CAUSE OF THE IDENTIFICATION ISSUE COULD BE LINKED TO A VITEK® MS KB LIMITATION WITH A BAD QUALITY OF SPECTRA, LINKED TO A NON-OPTIMAL SPOT PREPARATION OR/AND NON-OPTIMAL FINE TUNING. SIGNIFICANT IMPROVEMENTS HAVE ALREADY BEEN MADE BY R&D FOR THE NEXT VITEK® MS KB VERSION TO LIMIT MISIDENTIFICATION TO BRUCELLA SPP.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING A MISIDENTIFICATION OF ACTINOMYCES RADINGAE AS BRUCELLA SPP WHEN TESTING A PATIENT STRAIN WITH THE VITEK® MS INSTRUMENT. THE CUSTOMER TESTED THE SAME SPOT ON VITEK MS TWICE. THE FIRST TIME A "NO IDENTIFICATION" RESULT WAS OBTAINED. THE SECOND TIME A BRUCELLA SPP (99.9%) RESULT WAS OBTAINED. THE ISOLATE WAS SENT TO A LAB FOR SEQUENCING WITH 16S PCR AND ANOTHER MALDI-TOF TECHNIQUE (BRUCKER). SEQUENCING IDENTIFIED THE ORGANISM AS ACTINOMYCES RADINGAE. PER THE CUSTOMER, THE BRUCELLA SPP. RESULT WAS COMMUNICATED TO THE CLINICIANS, AND THE PATIENT WAS BEING TREATED FOR BRUCELLA INFECTION. THIS TREATMENT STARTED AFTER THE BRUCELLA SPP. RESULT WAS COMMUNICATED TO THE CLINICIANS. THERE IS NO FURTHER INFORMATION FROM THE CUSTOMER REGARDING THE IMPACT TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345449 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention