BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 12632977 · Received October 14, 2021

    Report

    Report Number
    9615754-2021-00273
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Report Date
    January 12, 2022
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN SWEDEN REPORTED TO BIOMÉRIEUX THAT THEY HAVE OBTAINED A POTENTIAL MISIDENTIFICATION OF YEAST AS MORAXELLA OSLOENSIS / ENHYDROBACTER AEROSACCUS WITH THE PRODUCT VITEK® MS INSTRUMENT (REF. 410895, SERIAL NUMBER (B)(6)). THERE WERE NO PATIENT OR OPERATOR DEATH, NO PATIENT OR OPERATOR HARMED, NO INDIRECT HARM PATIENT REPORTED, NO PATIENT HARMED/TREATED INCORRECTLY. INVESTIGATION: DEVICE HISTORY RECORD AND COMPLAINT DATABASE SEARCH: THE INVESTIGATOR SEARCHED THE BIOMÉRIEUX COMPLAINTS DATABASE FOR OTHER REPORTS OF THIS ISSUE. SINCE JANUARY 2016, NO OTHER COMPLAINTS HAVE BEEN RECORDED FOR A YEAST BEING IDENTIFIED (LOW DISCRIMINATION RESULT) AS MORAXELLA OSLOENSIS / ENHYDROBACTER AEROSACCUS. THERE IS NO CAPA, NO NON-CONFORMITY ON VITEK MS LINKED WITH CUSTOMER 'S COMPLAINT. FINE TUNING: FINE TUNING WAS NEEDED AT THE TIME OF ACQUISITION, ACCORDING TO THE VILINK ALERT TOOL CRITERIA, DURING THE TESTS MADE ON (B)(6) 2021 SPOT PREPARATION QUALITY: THE CUSTOMER¿S SPOT PREPARATION QUALITY WAS NOT OPTIMAL. THE CALIBRATOR AND SAMPLE ¿ALL PEAKS¿ VALUES WERE HETEROGENEOUS. KNOWLEDGE BASE (KB) REVIEW: THE EXPECTED IDENTIFICATION IS UNKNOWN BECAUSE NO REFERENCE METHOD WAS USED TO CONFIRM THE IDENTIFICATION. HOWEVER, THE CUSTOMER BELIEVES IT TO BE A YEAST. SAMPLE DATA ANALYSIS: THE INVESTIGATOR ANALYZED THE CUSTOMER'S MZML SAMPLE FILES WITH BACTERIA DATABASE. THIS CONFIRMED THE IDENTIFICATION PROVIDED BY THE CUSTOMER = LOW DISCRIMINATION TO MORAXELLA OSLOENSIS / ENHYDROBACTER AEROSACCUS. THE COMPLAINT LABORATORY WAS ABLE TO REPRODUCE THE IDENTIFICATION OBTAINED BY THE CUSTOMER. "ALL PEAKS¿ VALUES AND SCORES RANKING ARE GOOD. THE GRAM-STAIN RESULTS OBTAINED BY THE CUSTOMER SHOWED THE ORGANISM WAS LIKELY A YEAST. ANALYSIS OF MZML SAMPLE FILES WITH FUNGI DATABASE OBATINED "NO IDENTIFICATION" FOR ALL TESTS. BASED ON THESE FINDINGS, IT IT LIKELY CUSTOMER ERROR OCCURRED DURING THE SAMPLE PREPARATION : USE OF BACTERIA PROTOCOL INSTEAD OF YEAST PROTOCOL, OR USE OF BACTERIA DATABASE INSTEAD OF FUNGI DATABASE ON THE PREP STATION. THE INVESTIGATOR REQUESTED CLARIFICATION REGARDING THE PROTOCOL USED BUT NO INFORMATION WAS PROVIDED. AN OPERATOR ERROR IS SUSPECTED BUT IT IS NOT POSSIBLE TO CONFIRM THIS HYPOTHESIS BECAUSE THE STRAIN IS NOT AVAILABLE TO TEST. THERE ARE THE FOLLOWING LIMITATIONS IN THE USER MANUAL SUPPLEMENTS - 161150-923 - A - VITEK MS INDUSTRY USE - V3.2 KNOWLEDGE BASE : *ADDITIONAL LABORATORY TESTS AS DETERMINED BY MICROBIOLOGY LABORATORY PROTOCOLS FOR LOW DISCRIMINATION RESULTS ARE NECESSARY TO COMPLETE THE ORGANISM IDENTIFICATION. *NOTE: INTERPRETATION OF RESULTS AND USE OF THE VITEK® MS SYSTEM REQUIRE A COMPETENT LABORATORIAN WHO SHOULD JUDICIOUSLY MAKE USE OF EXPERIENCE, SAMPLE 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. REVIEW THE CONTEXT OF YOUR RESULT TO DETERMINE WHETHER THE VITEK® MS IDENTIFICATION IS CONSISTENT WITH YOUR ENVIRONMENT CONCLUSION: THE ROOT CAUSE OF THE ISSUE COULD NOT BE CONFIRMED. LOCAL CUSTOMER SERVICE (LCS) REVIEWED THE YEAST PROTOCOL USED TO PREPARE SPOTS FOR IDENTIFICATION; FUNGI MUST BE SELECTED ON THE PREP STATION AND USE BOTH FORMIC ACID + CHCA DURING SPOT PREPARATION. LCS ALSO PROVIDED THE CUSTOMER WITH ADDITIONAL TRAINING MATERIALS TO HELP IMPROVE THEIR SPOT PREPARATION TECHNIQUE.

    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 MOULD INFECTIONS. THE VITEK® MS SYSTEM AND THIS MANUAL ARE INTENDED FOR LABORATORY USE BY HEALTHCARE PROFESSIONALS WHO ARE TRAINED IN MICROBIOLOGY AND GOOD LABORATORY PRACTICES. INCIDENT DESCRIPTION: A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX THAT THEY HAVE OBTAINED A POTENTIAL MISIDENTIFICATION OF YEAST AS MORAXELLA OSLOENSIS/ENHYDROBACTER AEROSACCUS WITH THE PRODUCT VITEK MS INSTRUMENT (REF. 410895, SERIAL NUMBER (B)(4)). THE POTENTIAL ORGANISM MISIDENTIFICATION HAS NOT BEEN CONFIRMED, THE LOCAL CUSTOMER SERVICE HAS REQUESTED CUSTOMER TO PROVIDE FURTHER INFORMATION AND TO SUBMIT THE STRAIN TO ANALYZE THE IDENTIFICATION. 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. AN INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533198 VITEK MS INSTRUMENT VITEK MS INSTRUMENT QBN BIOMÉRIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown