BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 14780023 · Received June 22, 2022

    Report

    Report Number
    9615754-2022-00084
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Report Date
    June 30, 2025
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING NOTIFICATION FROM A CUSTOMER IN FRANCE THAT THEY OBTAINED A MISIDENTIFICATION OF ENTEROBACTER HORMAECHEI XIANGFANGENSIS AS KLEBSIELLA AEROGENES AND PAENIBACILLUS ODORIFER AS PREVOTELLA ORIS IN ASSOCIATION WITH VITEK MS INSTRUMENT (REF. 410895, SERIAL NUMBER: (B)(6)). THE CUSTOMER INDICATED THERE WAS NO PATIENT OR OPERATOR DEATH, NO PATIENT OR OPERATOR HARMED, NO INDIRECT HARM PATIENT REPORTED, NO PATIENT HARMED/TREATED INCORRECTLY. INVESTIGATION COMPLAINT ANALYSIS AND DEVICE HISTORY RECORD REVIEW. REVIEW OF THE COMPLAINTS DATABASE AND THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EVIDENCE THAT THIS IS A SYSTEMIC QUALITY PROBLEM. FINE TUNING: STATUS GOOD AT THE TIME OF ACQUISITION FOR LAB ID 22001261310101. STATUS UNDETERMINED AT THE TIME OF ACQUISITION FOR LAB ID 22001940130101 BECAUSE NO DATA WAS PROVIDED. SPOT PREPARATION QUALITY: THE CALIBRATOR ¿ALL PEAKS¿ VALUES ARE HOMOGENEOUS. CALIBRATOR SPOT PREPARATION SEEMS TO BE GOOD. HOWEVER, THE ¿SAMPLE DATA ANALYSIS¿ SHOWS THAT THE SAMPLE SPOT PREPARATION WAS NON OPTIMAL FOR AT LEAST ONE SAMPLE (LAB ID 22001261310101). KNOWLEDGE BASE REVIEW: THE EXPECTED IDENTIFICATION ENTEROBACTER HORMAECHEI XIANGFANGENSIS AND PAENIBACILLUS ODORIFER ARE NOT PRESENT IN VITEK MS KB V3.2. CUSTOMER DATA ANALYSIS: LAB ID 22001261310101: ENTEROBACTER HORMAECHEI XIANGFANGENSIS - ACCORDING TO DATA PROVIDED, THE MISIDENTIFICATION RESULT WAS OBTAINED FROM A SPECTRA HAVING A GOOD NUMBER OF PEAKS (81) AND AN ACCEPTABLE IDENTIFICATION SCORE (1.03). BIOMÉRIEUX QUALITY CONTROL LABORATORY DIDN¿T REPRODUCE THE VITEK MS CUSTOMER RESULTS AS KLEBSIELLA AEROGENES. THE FIVE SETS OF SPECTRA LED TO FOUR LOW DISCRIMINATION AS ENTEROBACTER HORMAECHEI - CLOACAE - ASBURIAE AND ONE LOW DISCRIMINATION AS ENTEROBACTER CLOACAE ¿ ASBURIAE. THESE LOW DISCRIMINATIONS WERE OBTAINED WITH LOW IDENTIFICATION SCORES. AS THE EXPECTED IDENTIFICATION ENTEROBACTER HORMAECHEI XIANGFANGENSIS IS NOT IN VITEK MS KB V3.2, VITEK MS GAVE MISIDENTIFICATION RESULTS. THE FOLLOWING SYSTEM LIMITATION IS MENTIONED IN THE VITEK MS KNOWLEDGE BASE USER MANUAL REF. 161150-924A FOR VITEK MS CLINICAL USE V3.2: ¿* 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.¿ REPROCESSING THE CUSTOMER DATA WITH VITEK MS KB V3.3 (IN DEVELOPMENT), SPECTRA LED TO A SINGLE CHOICE TO ENTEROBACTER HORMAECHEI SSP OHARAE/XIANGFANGENSIS. ANALYSIS OF THE CUSTOMER'S MZML SAMPLE FILES SHOWS THAT CUSTOMER SPECTRA B3 WAS VERY DIFFERENT FROM BIOMERIEUX QC LAB SPECTRA. BASED ON THESE FINDINGS, IN ADDITION TO THE SYSTEM LIMITATION ISSUE (SPECIES NOT PRESENT IN THE VITEK MS KB V3.2), THERE WAS PROBABLY A NON-OPTIMAL SPOT PREPARATION ISSUE FOR THIS SAMPLE STRAIN. LAB ID 22001940130101: BIOMÉRIEUX QUALITY CONTROL LABORATORY REPRODUCED THE VITEK MS CUSTOMER RESULTS AS PREVOTELLA ORIS. ONE SPECTRA LED TO NO IDENTIFICATION AND FOUR SPECTRA LED TO SINGLE CHOICE AS PREVOTELLA ORIS. REPROCESSING THE CUSTOMER DATA WITH NEXT VITEK MS KB V3.3 (IN DEVELOPMENT), LED TO THE SAME RESULT.. EXPECTED IDENTIFICATION: BASED ON THE 16S RNA SEQUENCING RESULTS, THE EXPECTED IDENTIFICATION IS PAENIBACILLUS ODORIFER. THIS SPECIES IS NOT INCLUDED IN THE VITEK MS KNOWLEDGE BASE V3.2. THE FOLLOWING SYSTEM LIMITATION IS MENTIONED IN THE VITEK MS KNOWLEDGE BASE USER MANUAL REF. 161150-924A FOR VITEK MS CLINICAL USE V3.2: ¿* 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.¿ CONCLUSION THE INVESTIGATION INDICATES THIS CUSTOMER ISSUE OCCURRED DUE TO A KNOWN SYSTEM LIMITATION REGARDING HOW THE SOFTWARE HANDLES SPECTRA FOR SPECIES NOT PRESENT IN THE KNOWLEDGE BASE). TWO CHANGE REQUESTS RELATED TO THE REPORTED ISSUES HAVE BEEN INITIATED BY R&D FOR KNOWLEDGE BASE REVIEW/IMPROVEMENT.

    Additional Manufacturer Narrative · 0

    IN ALIGNMENT WITH THE MOST RECENT FDA GUIDANCE, ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS, ISSUED NOVEMBER 8, 2016¿, BIOMÉRIEUX IS SUBMITTING THIS NOTIFICATION TO FDA TO INFORM THE AGENCY OF THE DECISION TO CEASE REPORTING SPECIFIC VITEK® MS AND VITEK® MS PRIME MALFUNCTION EVENTS AFTER TWO YEARS OF NO OCCURRENCES ASSOCIATED WITH DEATH OR SERIOUS INJURY. FOR THE SPECIFIC COMBINATIONS OF PRODUCT AND MALFUNCTION TYPE, CUSTOMER COMPLAINTS WERE REVIEWED OVER A TWO YEAR PERIOD STARTING FROM THE DATE OF AWARENESS OF THE MOST RECENT EVENT THAT WAS CLASSIFIED AS A SERIOUS INJURY OR DEATH. FOR THE FOLLOWING MALFUNCTION TYPES, THIS REVIEW IDENTIFIED NO ADDITIONAL OCCURRENCES OF BEING ASSOCIATED WITH DEATH OR SERIOUS INJURY FOR TWO YEARS. PRODUCT CODE: QBN. REFERENCE: (B)(4). MALFUNCTION: MISIDENTIFICATION OF PAENIBACILLUS ODORIFER AS PREVOTELLA ORIS. DATE OF AWARENESS FOR SERIOUS INJURY/DEATH: 24MAY2022. FINAL INITIAL MDR SUBMITTED: 9615754-2022-00084 . CEASE REPORTING DECISION MDR: 9615754-2022-00084-02. PRODUCT CODE: QBN. REFERENCE: (B)(4). MALFUNCTION: MISIDENTIFICATION OF ENTEROBACTER HORMAECHEIXIANGFANENSIS AS KLEBSIELLA AEROGENES. DATE OF AWARENESS FOR SERIOUS INJURY/DEATH: 24MAY2022. FINAL INITIAL MDR SUBMITTED: 9615754-2022-00084. CEASE REPORTING DECISION MDR: 9615754-2022-00084-02. WITH THE COMPLETION OF OUR MDR DATA ANALYSIS, WE HAVE UPDATED OUR MDR CRITERIA FOR VITEK MS AND VITEK MS PRIME PRODUCT CODE QBN AND WILL NO LONGER REPORT THESE MALFUNCTION EVENTS SINCE THEY HAVE NOT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY IN THE PAST TWO YEARS. MOVING FORWARD, IF BIOMÉRIEUX BECOMES AWARE OF A DEATH OR SERIOUS INJURY EVENT FOR THE PRODUCT CODES QBN WE WILL REPORT THAT EVENT TO THE FDA PER THE FDA MDR GUIDANCE AND WILL UPDATE OUR MDR CRITERIA TO REQUIRE REPORTING THE SPECIFIC ASSOCIATED MALFUNCTION AS REQUIRED BY THIS GUIDANCE.

    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: ON (B)(6) 2022, A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF THE MISIDENTIFICATION OF ENTEROBACTER HORMAECHEI XIANGFANGENSIS AS KLEBSIELLA AEROGENES, AND PAENIBACILLUS ODORIFER AS PREVOTELLA ORIS, IN ASSOCIATION WITH VITEK MS INSTRUMENT ((B)(4)). SUMMARY OF RESULTS: SAMPLE: (B)(6); VITEK MS: IDENTIFIED AS KLEBSIELLA AEROGENES; ALTERNATE METHOD (ILLUMINA COMPLETE SEQUENCING): IDENTIFIED AS ENTEROBACTER HORMAECHEI XIANGFANGENSIS. SAMPLE (B)(6); VITEK MS: IDENTIFIED AS PREVOTELLA ORIS; ALTERNATE METHOD (16S SEQUENCING): IDENTIFIED AS PAENIBACILLUS ODORIFER. REVIEW OF THE PROVIDED INFORMATION INDICATED: LAB ID (B)(6) IDENTIFIED AS KLEBSIELLA AEROGENES. THIS IS A KNOWN SYSTEM LIMITATION AS ENTEROBACTER HORMAECHEI XIANGFANGENSIS IS NOT PRESENT IN THE VITEK MS KNOWLEDGE BASE (KB). LAB ID (B)(6) IDENTIFIED AS PREVOTELLA ORIS. THIS IS A KNOWN SYSTEM LIMITATION AS PAENIBACILLUS ODORIFER IS NOT PRESENT IN THE VITEK MS KB. THE FOLLOWING SYSTEM LIMITATION IS STATED IN THE VITEK MS V3.2 KNOWLEDGE BASE USER MANUAL REF. (B)(4): ¿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.¿ AT THE TIME OF THE INITIAL ASSESSMENT, DESPITE MULTIPLE ATTEMPTS, INFORMATION COULD NOT BE OBTAINED FROM THE CUSTOMER REGARDING ANY PATIENT IMPACT. UPDATE (8-JUN-2022): FOLLOWING INITIAL EVALUATION OF THIS REPORTED EVENT, THE CUSTOMER NOTIFIED BIOMÉRIEUX ON (B)(6) 2022 THAT THE PATIENT ASSOCIATED WITH ISOLATE ID (B)(6) HAD RECEIVED ANTIBIOTIC TREATMENT BASED ON THE VITEK MS RESULT (DETAILS NOT PROVIDED) WHICH WAS SUBSEQUENTLY MODIFIED/REMOVED WHEN THE ASSOCIATED SEQUENCING TEST RESULT WAS PROVIDED/UPDATED. THERE WAS NO INDICATION OF ADVERSE IMPACT TO THE PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320883 VITEK MS INSTRUMENT VITEK MS INSTRUMENT QBN BIOMÉRIEUX SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention