BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS

    MDR report key: 9440189 · Received December 9, 2019

    Report

    Report Number
    9615754-2019-00135
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Report Date
    December 9, 2019
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    PMA / PMN Number
    DEN130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. CONCLUSION ON THE FINE TUNING: THE ANALYSIS OF THE CALIBRATOR MZML FILES INDICATED THAT NO FINE-TUNING WAS REQUIRED FOR THE TESTS PERFORMED ON 17-OCT-2019. CONCLUSION ON SPOT PREPARATION QUALITY: THE CUSTOMER'S SPOT PREPARATION QUALITY IS NOT OPTIMAL. THE CALIBRATOR AND SAMPLE "ALL PEAKS" VALUES ARE QUITE HETEROGENEOUS. THIS COULD BE EXPLAINED BY A NON-OPTIMAL SPOT PREPARATION (CULTURE, SPOT, DIFFERENT OPERATOR...). CONCLUSION ON THE IDENTIFICATION: ACCORDING TO THE PROVIDED CUSTOMER DATA, THE NUMBER OF ALL PEAKS ARE HETEROGENEOUS DURING THE ISSUE. THE MISIDENTIFICATION RESULT OF STREPTOCOCCUS CONSTELLATUS IS OBTAINED FROM THE SPECTRA HAVING THE LOWER NUMBER OF PEAKS AND LOWER SCORE (-0.38). THIS CRITERIA IS NEAR THE LIMIT (-0.4) FOR GIVING AN "IDENTIFICATION" RESULT OR A "NO IDENTIFICATION" RESULT. THIS COULD BE EXPLAINED BY A NON-OPTIMAL SPOT PREPARATION OF THE SAMPLE STRAIN (CULTURE, SPOT, DIFFERENT OPERATOR...). SUSPECTED CAUSE: NON-OPTIMAL SAMPLE SPOT PREPARATION BY THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING A DISCREPANT IDENTIFICATION RESULT FROM A URINE SAMPLE WHEN TESTING WITH THE VITEK® MS INSTRUMENT. VITEK® MS OBTAINED IDENTIFICATION OF STREPTOCOCCUS CONSTELLATUS 99.3%. UPON REPEAT TESTING, THE CUSTOMER REPORTED THAT THE CORRECT IDENTIFICATION OF STREPTOCOCCUS AGALACTIAE 99.9% WAS OBTAINED. ALTERNATE TESTING RESULTS: OXOID STREP LATEX AGGLUTINATION: LANCEFIELD GROUPING B. API 20 STREP: STREPTOCOCCUS AGALACTIAE (3063014). COLONIES MORPHOLOGICAL INSPECTION: = BETA-HAEMOLYTIC STREPTOCOCCUS AGALACTIAE-LIKE COLONIES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. THE FINAL REPORTED ID WAS STREPTOCOCCUS AGALACTIAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234711 VITEK® MS VITEK MS INSTRUMENT PEX BIOMERIEUX, SA 4700394

    Patients

    Seq Age Sex Outcome Treatment
    1