BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11614741 · Received April 5, 2021

    Report

    Report Number
    9615754-2021-00040
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Report Date
    June 25, 2021
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. INVESTIGATOR REVIEWED THE HISTORICAL RECORDS IN THE COMPLAINTS DATABASE TO DETERMINE WHETHER ANY SIMILAR REPORTS HAVE BEEN DOCUMENTED. SINCE JANUARY 2016, NO SIMILAR COMPLAINTS (C. HAEMULONII AND C. METAPSILOSIS) HAVE BEEN DOCUMENTED. THE DEFINITIVE ID WAS DETERMINED BY SEQUENCING THE D1-D2 REGION OF THE 28S RRNA GENES AND ITS REGION OF EACH ISOLATE. NO EXISTING CAPAS NOR NON-CONFORMITIES WERE IDENTIFIED THAT COULD BE LINKED WITH THIS REPORT. LOCAL CUSTOMER SERVICE REQUESTED FURTHER INFORMATION FROM THE CUSTOMER. FOLLOWING SEVERAL ATTEMPTS TO COLLECT ADDITIONAL INFORMATION, THE CUSTOMER WAS UNABLE TO PROVIDE ANY OTHER RELEVANT DATA OR SAMPLES OF THE ISOLATES IN QUESTION. CONCLUSION. ORGANISM WAS IDENTIFIED AS C. KRUSEI VIA SEQUENCING. THE MISIDENTIFICATION DOES NOT APPEAR TO BE CAUSED BY ANY PERFORMANCE ISSUE, BUT THIS CANNOT BE CONFIRMED WITHOUT THE SAMPLE AND ADDITIONAL INFORMATION FROM THE CUSTOMER. ROOT CAUSE. CAUSE NOT ESTABLISHED - ROOT CAUSE COULD NOT BE ESTABLISHED DUE TO LACK OF ADDITIONAL INFORMATION AND LACK OF ACCESS TO ANY OF THE MENTIONED SAMPLES. CORRECTIVE AND PREVENTATIVE ACTION. NO CAPA NUMBER IS REQUIRED AS THE ROOT CAUSE CANNOT BE DETERMINED AND THERE IS NO EVIDENCE THAT THIS IS A RECURRING OR SYSTEMIC QUALITY ISSUE.

    Description of Event or Problem · 1

    AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A SCIENTIFIC PUBLICATION ENTITLED ""SPECIES IDENTIFICATION AND ANTIFUNGAL SUSCEPTIBILITY OF UNCOMMON BLOOD YEAST ISOLATES." JOURNAL OF MICROBIOLOGY, IMMUNOLOGY, AND INFECTION BY WEI MIAN YU GAN RAN ZA ZHI ET AL. 2021. THIS PUBLICATION DOCUMENTS A MISIDENTIFICATION OF CANDIDA HAEMULONII AS A CANDIDA KRUSEI. ACCORDING TO THE PUBLICATION, ONE HUNDRED THIRTY-SIX UNCOMMON BLOOD YEAST ISOLATES COLLECTED BETWEEN 2011 AND 2016 WERE USED TO COMPARE THE FOLLOWING SYSTEMS' PERFORMANCE, VITEK MS, THE BRUKER MALDI-TOF BIOTYPER, AND THE OLIGONUCLEOTIDE ARRAY, AT IDENTIFYING UNCOMMON CANDIDA SPECIES. THE DEFINITIVE ID WAS DONE BY SEQUENCING THE D1-D2 REGION OF THE 28S RRNA GENES AND ITS REGION. AS THE STUDY IS RETROSPECTIVE, THE MISIDENTIFICATION DIDN'T LEAD TO ANY PATIENT IMPACT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510040 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1