BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS INSTRUMENT

    MDR report key: 15829442 · Received November 18, 2022

    Report

    Report Number
    9615754-2022-00129
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Report Date
    January 6, 2023
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED RELATED TO A PUBLICATION IN KOREA REPORTING MISIDENTIFICATIONS OF SALMONELLA PARATYPHI A, SALMONELLA SER. TYPHI, AND SALMONELLA ENTERICA SSP. DIARIZONAE AS SALMONELLA GROUP IN ASSOCIATION WITH VITEK MS INSTRUMENT (REF. (B)(4), LOT UNKNOWN). PERFORMANCE OF MALDI-TOF MASS SPECTROMETRY (VITEK MS) IN THE IDENTIFICATION OF SALMONELLA SPECIES. MICROORGANISMS . 2022 , 10 ( 10 ) KIM, GYU RI / KIM, SI HYUN / KIM, EUN-YOUNG / PARK, EUN HEE / HWANG, IN YEONG / JEONG, SEOK HOON / KIM, HYUN SOO / KIM, YOUNG AH / UH, YOUNG / SHIN, KYEONG SEOB / KIM, YOUNG REE / RYOO, NAMHEE / SHIN, JONG HEE / SHIN, JEONG HWAN. ---DESCRIPTION--- VITEK MS MODE : IVD KB VERSION : 3.0 AND 3.2. ISSUE TYPE : MISIDENTIFICATION FOR SALMONELLA SPECIES. EXPECTED ID: (B)(4) OTHER METHOD : VITEK2, BRUKER, SEROTYPING. CULTURE: 1389 SALMONELLA ISOLATES -ORIGIN : STOOL; BLOOD, URINE, BODY FLUIDS AND TISSUES -CULTURE MEDIA : UNKNOWN -INCUBATION: UNKNOWN. ---INVESTIGATION--- FOR VITEK MS KB V3.2 THE DISPLAYED IDENTIFICATION "SALMONELLA ENTERICA SSP ENTERICA" INCLUDES THE FOLLOWING SUBSPECIES : SALMONELLA SER.ENTERITIDIS, SALMONELLA SER.GALLINARUM, SALMONELLA SER.PARATYPHI A, SALMONELLA SER.PARATYPHI B, SALMONELLA SER.PARATYPHI C, SALMONELLA SER.TYPHI, SALMONELLA SER.TYPHIMURIUM. FOR THOSE IDENTIFICATIONS A NOTE IN THE VITEK MS USER MANUALS INDICATES THAT THEY SHOULD BE CONFIRMED BY SEROLOGICAL TESTS: ¿CONFIRMATION OF IDENTIFICATION BY SEROLOGICAL TESTS FOR SALMONELLA ENTERICA SPP ENTERICA¿. THE FOLLOWING SYSTEM LIMITATION IS INCLUDED IN THE VITEK MS KNOWLEDGE BASE USER MANUAL REF. 161150-924 ¿ A FOR VITEK MS CLINICAL USE V3.2: ¿* THE VITEK MS SYSTEM HAS NOT BEEN VALIDATED FOR USE WITH DIRECT SAMPLES OR FROM OTHER SOURCES CONTAINING MIXED FLORA. * ADDITIONAL LABORATORY TESTS AS DETERMINED BY MICROBIOLOGY LABORATORY PROTOCOLS FOR LOW DISCRIMINATION RESULTS ARE NECESSARY FOR THE COMPLETION OF THE ORGANISM IDENTIFICATION. * TESTING OF SPECIES NOT FOUND IN THE DATABASE MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION. * INTERPRETATION OF RESULTS AND USE OF THE VITEK MS SYSTEM REQUIRE A COMPETENT LABORATORIAN WHO SHOULD JUDICIOUSLY MAKE USE OF EXPERIENCE, SPECIMEN INFORMATION, AND OTHER PERTINENT PROCEDURES BEFORE REPORTING THE IDENTIFICATION OF TEST ORGANISMS. ADDITIONAL INFORMATION KNOWN TO THE USER, SUCH AS GRAM STAIN REACTION, COLONIAL AND CELLULAR MORPHOLOGY, AND GROWTH AEROBICALLY OR IN CO2 SHOULD BE CONSIDERED WHEN ACCEPTING VITEK MS RESULTS.¿ 3. ROOT CAUSE ANALYSIS SYSTEM LIMITATION ---CONCLUSION--- REVIEW OF THE PUBLICATION INDICATED THAT FOR VITEK MS KB V3.2 THE DISPLAYED IDENTIFICATION "SALMONELLA ENTERICA SSP ENTERICA" INCLUDES THE FOLLOWING SUBSPECIES : SALMONELLA SER.ENTERITIDIS, SALMONELLA SER.GALLINARUM, SALMONELLA SER.PARATYPHI A, SALMONELLA SER.PARATYPHI B, SALMONELLA SER.PARATYPHI C, SALMONELLA SER.TYPHI, SALMONELLA SER.TYPHIMURIUM. FOR THOSE IDENTIFICATIONS A NOTE PRECISES IN THE VITEK MS USER MANUALS THAT THEY SHOULD BE CONFIRMED BY SEROLOGICAL TESTS: ¿CONFIRMATION OF IDENTIFICATION BY SEROLOGICAL TESTS FOR SALMONELLA ENTERICA SPP ENTERICA¿. THERE IS THEN NO EVIDENCE THAT VITEK MS KB V3.2 IS OUT OF ITS EXPECTED LEVEL OF PERFORMANCES. GLOBAL CUSTOMER SERVICE (GCS) PERFORMED A COMPLAINT TREND ANALYSIS AND DID NOT IDENTIFY THIS ISSUE AS A TREND.

    Description of Event or Problem · 0

    INTENDED USE: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS SYSTEM IS A QUALITATIVE IN-VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL, YEAST AND MOLD INFECTIONS. ISSUE DESCRIPTION: A PUBLICATION IN KOREA (PERFORMANCE OF MALDI-TOF MASS SPECTROMETRY (VITEK MS) IN THE IDENTIFICATION OF SALMONELLA SPECIES. MICROORGANISMS . 2022 , 10 ( 10 ) KIM, GYU RI ET.AL.) REPORTED MISIDENTIFICATIONS OF SALMONELLA PARATYPHI A, SALMONELLA SER. TYPHI, AND SALMONELLA ENTERICA SSP. DIARIZONAE AS SALMONELLA GROUP IN ASSOCIATION WITH VITEK MS INSTRUMENT (REF. 410895, SERIAL NUMBER UNKNOWN) KNOWLEDGE BASE VERSION 3.0 AND MISIDENTIFICATIONS OF SALMONELLA ENTERICA SSP. DIARIZONAE AS SALMONELLA ENTERICA SSP. ENTERICA IN ASSOCIATION WITH VITEK MS INSTRUMENT (REF. (B)(4), SERIAL NUMBER UNKNOWN) KNOWLEDGE BASE VERSION 3.2. THERE WAS NO INDICATION OR REPORT FROM THE CUSTOMER OF ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THIS PUBLICATION WAS REVIEWED BY BIOMÉRIEUX MEDICAL AFFAIRS AND RESEARCH AND DEVELOPMENT. MEDICAL AFFAIRS: THIS REPORT DESCRIBES A THE PERFORMANCE OF THE VITEK MS SYSTEM AT IDENTIFYING A COLLECTION OF (B)(4) SALMONELLA ISOLATES, COVERING 66 SEROTYPES. THE AUTHORS USED VITEK MS WITH KB 3.0 AND 3.2 DURING THIS STUDY. ALL 1,389 ISOLATES (100%) WERE CORRECTLY IDENTIFIED TO THE GENUS LEVEL. THE VITEK MS KB 3.0 FAILED TO CORRECTLY IDENTIFY 11 OF 14 PARATYPHI A ISOLATES. FOR KB 3.2, OF THE 3 ISOLATES OF S. ENTERICA SSP. DIARIZONAE TESTED, 2 WERE MISIDENTIFIED AS S. ENTERICA SSP. ENTERICA. THE AUTHORS CONCLUDE THAT THE VITEK MS SYSTEM SHOWS EXCELLENT PERFORMANCE AT IDENTIFYING SALMONELLA ISOLATES, BUT THAT ADDITIONAL BIOCHEMICAL AND/OR SEROTYPING METHODS ARE NECESSARY FOR DEFINITIVE IDENTIFICATION OF TYPHOIDAL ISOLATES. RESEARCH AND DEVELOPMENT: THE ARTICLE PRESENTS A STUDY WHICH OBJECTIVE WAS TO EVALUATE THE PERFORMANCE OF THE VITEK MS SYSTEM AT IDENTIFYING A COLLECTION OF (B)(4) SALMONELLA ISOLATES, COVERING 66 SEROTYPES. KB 3.0 AND 3.2 WERE USED FOR THIS STUDY AND THE STRAINS WERE TESTED WITH SEROLOGICAL TESTS. THE ARTICLE STATES THAT VITEK MS RESULTS HAVE TO BE CONFIRMED ON TYPHOIDAL SALMONELLA SPP. FOR VITEK MS KB 3.2 THE DISPLAYED IDENTIFICATION "SALMONELLA ENTERICA SSP ENTERICA" INCLUDES THE SUBSPECIES LISTED BELOW: SALMONELLA SER.ENTERITIDIS SALMONELLA SER.GALLINARUM SALMONELLA SER.PARATYPHI A SALMONELLA SER.PARATYPHI B SALMONELLA SER.PARATYPHI C SALMONELLA SER.TYPHI SALMONELLA SER.TYPHIMURIUM FOR THOSE IDENTIFICATIONS A NOTE INDICATES THAT THEY SHOULD BE CONFIRMED BY SEROLOGICAL TESTS. THERE IS THEN NO EVIDENCE THAT VITEK MS KB 3.2 IS OUT OF ITS EXPECTED LEVEL OF PERFORMANCES.

    Description of Event or Problem · 0

    INTENDED USE: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS SYSTEM IS A QUALITATIVE IN-VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL, YEAST AND MOLD INFECTIONS. ISSUE DESCRIPTION: A PUBLICATION IN KOREA (PERFORMANCE OF MALDI-TOF MASS SPECTROMETRY (VITEK MS) IN THE IDENTIFICATION OF SALMONELLA SPECIES. MICROORGANISMS . 2022 , 10 ( 10 ) KIM, GYU RI ET.AL.) REPORTED MISIDENTIFICATIONS OF SALMONELLA PARATYPHI A, SALMONELLA SER. TYPHI, AND SALMONELLA ENTERICA SSP. DIARIZONAE AS SALMONELLA GROUP IN ASSOCIATION WITH VITEK MS INSTRUMENT (REF. 410895, SERIAL NUMBER UNKNOWN) KNOWLEDGE BASE VERSION 3.0 AND MISIDENTIFICATIONS OF SALMONELLA ENTERICA SSP. DIARIZONAE AS SALMONELLA ENTERICA SSP. ENTERICA IN ASSOCIATION WITH VITEK MS INSTRUMENT (REF. 410895, SERIAL NUMBER UNKNOWN) KNOWLEDGE BASE VERSION 3.2. AT THE TIME OF ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THIS PUBLICATION WAS REVIEWED BY MEDICAL AFFAIRS AND RESEARCH AND DEVELOPMENT. MEDICAL AFFAIRS: THIS REPORT DESCRIBES A THE PERFORMANCE OF THE VITEK MS SYSTEM AT IDENTIFYING A COLLECTION OF 1,389 SALMONELLA ISOLATES, COVERING 66 SEROTYPES. THE AUTHORS USED VITEK MS WITH KB 3.0 AND 3.2 DURING THIS STUDY. ALL 1,389 ISOLATES (100%) WERE CORRECTLY IDENTIFIED TO THE GENUS LEVEL. THE VITEK MS KB 3.0 FAILED TO CORRECTLY IDENTIFY 11 OF 14 PARATYPHI A ISOLATES. FOR KB 3.2 OF THE 3 ISOLATES OF S. ENTERICA SSP. DIARIZONAE TESTED, 2 WERE MISIDENTIFIED AS S. ENTERICA SSP. ENTERICA. THE AUTHORS CONCLUDE THAT THE VITEK MS SYSTEM SHOWS EXCELLENT PERFORMANCE AT IDENTIFYING SALMONELLA ISOLATES, BUT THAT ADDITIONAL BIOCHEMICAL AND/OR SEROTYPING METHODS ARE NECESSARY FOR DEFINITIVE IDENTIFICATION OF TYPHOIDAL ISOLATES. RESEARCH AND DEVELOPMENT: THIS ARTICLE PRESENTS A STUDY WHICH OBJECTIVE WAS TO EVALUATE THE PERFORMANCE OF THE VITEK MS SYSTEM AT IDENTIFYING A COLLECTION OF 1,389 SALMONELLA ISOLATES, COVERING 66 SEROTYPES. KB 3.0 AND 3.2 WERE USED FOR THIS STUDY AND THE STRAINS WERE TESTED WITH SEROLOGICAL TESTS. THE ARTICLE STATES THAT VITEK MS RESULTS HAVE TO BE CONFIRMED ON TYPHOIDAL SALMONELLA SPP. FOR VITEK MS KB 3.2 THE DISPLAYED IDENTIFICATION "SALMONELLA ENTERICA SSP ENTERICA" INCLUDES THE SUBSPECIES LISTED BELOW: SALMONELLA SER.ENTERITIDIS SALMONELLA SER.GALLINARUM SALMONELLA SER.PARATYPHI A SALMONELLA SER.PARATYPHI B SALMONELLA SER.PARATYPHI C SALMONELLA SER.TYPHI SALMONELLA SER.TYPHIMURIUM FOR THOSE IDENTIFICATIONS A NOTE INDICATES THAT THEY SHOULD BE CONFIRMED BY SEROLOGICAL TESTS. THERE IS THEN NO EVIDENCE THAT VITEK MS KB 3.2 IS OUT OF ITS EXPECTED LEVEL OF PERFORMANCES. VITEK MS KB3.0 WAS ALSO USED BUT KB HAS BEEN IMPROVED BETWEEN KB3.0 AND KB3.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615064 VITEK® MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown