BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS

    MDR report key: 11640986 · Received April 9, 2021

    Report

    Report Number
    9615754-2021-00044
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF A MISIDENTIFICATION OF A STAPHYLOCOCCUS SPECIES AS A STREPTOCOCCUS SPECIES WHEN TESTING A PATIENT ISOLATE WITH THE VITEK® MS (REF 410895, SERIAL 51203). THE CUSTOMER'S RAW DATA WAS ANALYZED FOR THIS INVESTIGATION. FINE TUNING: ACCORDING TO VILINK ALERT TOOL CRITERIA, NO FINE TUNING WAS NEEDED DURING CUSTOMER¿S TESTS. SPOT PREPARATION QUALITY: THE SPOT PREPARATION WAS NON-OPTIMAL. THE CALIBRATOR "ALL PEAKS" VALUES WERE QUITE HETEROGENOUS. SAMPLE DATA ANALYSIS: BASED ON THE RAW DATA PROVIDED, THE CULTURE SEEMS TO CONTAIN TWO DIFFERENT COLONY TYPES. LARGE COLONIES AND SMALL COLONIES. REPROCESSING THE CUSTOMER DATA FROM LAB ID T14339LARGE WITH VITEK MS KB V3.2 ALLOWS TO GET A SINGLE CHOICE TO STREPTOCOCCUS MITIS/STREPTOCOCCUS ORALIS AND A LOW DISCRIMINATION TO MORAXELLA (NEISSERIA) OVIS - MORAXELLA LACUNATA. DUPLICATE SPOTS GAVE DIFFERENT RESULTS, IT COULD BE A POTENTIAL MISIDENTIFICATION. THE IDENTIFICATION TO STREPTOCOCCUS MITIS/STREPTOCOCCUS ORALIS WAS OBTAINED WITH A GOOD SCORE (1.69). IN REVERSE, THE LOW DISCRIMINATION TO MORAXELLA (NEISSERIA) OVIS - MORAXELLA LACUNATA HAD A LOW SCORE (-0.37) WHICH IS NEAR THE ACCEPTABLE LIMIT (-0.4) FOR GIVING AN ¿IDENTIFICATION¿ RESULT OR A ¿NO IDENTIFICATION¿ RESULT. REPROCESSING THE CUSTOMER DATA FROM LAB ID T14339SMALL WITH VITEK MS KB V3.2 ALLOWS TO GET TWO SINGLE CHOICE TO STREPTOCOCCUS PNEUMONIAE. BOTH SPOTS GAVE SIMILAR RESULTS. IT COULD BE THE MOST PROBABLE IDENTIFICATION. THE DENDROGRAM OF CUSTOMER SPECTRA ALLOWS TO SHOW THAT LAB ID T14339LARGE AND LAB ID T14339SMALL ARE DIFFERENT, THE CULTURE COULD CONTAIN TWO DIFFERENT ORGANISMS (LARGE COLONIES AND SMALL COLONIES) BECAUSE THE RELATIVE SIMILARITY IS UNDER THE LIMIT OF 65%. FURTHER ANALYSIS OF THE SAMPLE IS NEEDED TO CONFIRM THIS HYPOTHESIS. THE CUSTOMER'S SAMPLE WAS REQUESTED FOR ADDITIONAL INVESTIGATIONAL TESTING, BUT THE CUSTOMER WAS UNABLE TO PROVIDE THE SAMPLE. THE EXPECTED IDENTIFICATION COULD NOT BE ESTABLISHED SINCE THE SAMPLE COULD NOT BE PROVIDED AND NO REFERENCE METHOD TESTING (SEQUENCING) WAS PERFO ROOT CAUSE: THE CAUSE FOR THE CUSTOMER'S ISSUE COULD NOT BE IDENTIFIED AS ADDITIONAL INVESTIGATIONAL TESTING WOULD BE REQUIRED TO DETERMINE THE EXPECTED IDENTIFICATION AND ESTABLISH A CAUSE FOR A MISIDENTIFICATION. SINCE THE CUSTOMER WAS UNABLE TO PROVIDE THE SAMPLE FOR ANALYSIS, NO FURTHER INVESTIGATION COULD BE COMPLETED. CONCLUSION: THE EXPECTED IDENTIFICATION OF THE CUSTOMER'S STRAIN(S) COULD NOT BE VERIFIED SINCE THE CUSTOMER COULD NOT PROVIDE THE SAMPLE FOR ANALYSIS AND SEQUENCING WAS NOT PERFORMED. THE CAUSE FOR THE CUSTOMER'S ISSUE COULD NOT BE DETERMINED WITHOUT FURTHER ANALYSIS OF THE CUSTOMER'S STRAIN(S).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF OBTAINING A MISIDENTIFICATION OF A STAPHYLOCOCCUS SPECIES AS A STREPTOCOCCUS SPECIES WHEN TESTING A PATIENT ISOLATE WITH THE VITEK¿ MS (REF 410895, SERIAL (B)(4). THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOM¿RIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538646 VITEK MS VITEK® MS QBN BIOMÉRIEUX SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1