BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS

    MDR report key: 10162205 · Received June 17, 2020

    Report

    Report Number
    9615754-2020-00088
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Report Date
    June 17, 2020
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    UDI-DI
    03573026359119
    PMA / PMN Number
    DEN130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED. COMPLAINT TREND ANALYSIS AND DEVICE HISTORY RECORD: A TREND ANALYSIS WAS COMPLETED REGARDING THE COMPLAINTS RECORDED FOR A MISIDENTIFICATION DUE TO AN "FINE TUNING THAT HAS DRIFTED UNDER THE VILINK ALERT TOOL CRITERIA" AND "NON OPTIMAL SPOT PREPARATION". PROBABILITY AS PER SAFETY RISK MANAGEMENT PROCEDURE (B)(4): IMPROBABLE. THERE IS NO CAPA, NO NON CONFORMITY ON VITEK MS LINKED WITH CUSTOMER 'S COMPLAINT. AS THE EXPECTED IDENTIFICATION IS UNKNOWN, IT WAS NOT POSSIBLE TO DETERMINE IF OTHER SIMILAR ISSUES HAVE ALREADY BEEN OBSERVED. INVESTIGATION: FINE TUNING: THE STATUS WAS NOT OPTIMUM AT THE TIME OF ACQUISITION. SPOT PREPARATION QUALITY: THE CALIBRATOR SPOT PREPARATION: QUALITY WAS NOT OPTIMAL. THE CALIBRATOR "ALL PEAKS" VALUES WERE QUITE HETEROGENEOUS. THIS COULD BE EXPLAINED BY A NON-OPTIMAL SPOT PREPARATION OF THE CALIBRATOR STRAIN (CULTURE, SPOT, DIFFERENT OPERATOR). KNOWLEDGE BASE (KB) REVIEW: THE EXPECTED IDENTIFICATION IS UNKNOWN, SO IT WAS NOT POSSIBLE TO STATE IF THE STRAINS TESTED WERE PRESENT IN VITEK MS KB USED BY THE CUSTOMER. CUSTOMER WOULD HAVE TO CONFIRM THE IDENTIFICATION WITH A REFERENCE METHOD, SUCH AS SEQUENCING. SAMPLE DATA ANALYSIS: THE CUSTOMER'S DATA WAS REPROCESSED USING VITEK MS KB (B)(4), HOWEVER; THE CUSTOMER'S RESULTS WERE NOT DUPLICATED. LAB ID (B)(6): LOW DISCRIMINATION TO AEROMONAS SOBRIA - AEROMONAS VERONII INSTEAD OF SINGLE CHOICE OF AEROMONAS VERONII. FOR LOW DISCRIMINATION IDENTIFICATION RESULTS, IT IS NOT THE FINAL RESULT, AS MENTIONED IN THE LIMITS WRITTEN IN THE VITEK MS KNOWLEDGE BASE USER MANUAL :"ADDITIONAL LABORATORY TESTS AS DETERMINED BY MICROBIOLOGY LABORATORY PROTOCOLS FOR LOW DISCRIMINATION RESULTS ARE NECESSARY TO COMPLETE THE ORGANISM IDENTIFICATION. " MOREOVER, THERE IS THE FOLLOWING 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." THE NUMBER OF PEAKS DETECTED WAS LOW FOR LAB ID (B)(6). THE POTENTIAL IDENTIFICATION ISSUE WAS OBTAINED FROM THE SPECTRA HAVING THE LOWER NUMBER OF PEAKS (WHICH IS CLOSE TO THE ACCEPTABLE LIMIT FOR GIVING AN "IDENTIFICATION" RESULT OR A "NO IDENTIFICATION" RESULT). THE LOW QUANTITY OF PEAKS PRESENT IN THE SPECTRA ACQUIRED IS AN INDICATION THAT A FINE TUNING WAS NEEDED DURING CUSTOMER TESTS. THE SYSTEM WAS NOT ABLE TO DETECT THE APPROPRIATE AMOUNT OF PEAKS TO EFFECTIVELY IDENTIFY THE SAMPLES. THE DATA WAS ANALYZED WITH KNOWLEDGE BASE (KB) VERSION (B)(4) AND FOUR OUT OF FIVE TESTS GAVE A NO IDENTIFICATION RESULT. THERE WAS ONLY ONE POTENTIAL IDENTIFICATION ISSUE. IT IS RECOMMENDED THAT THE CUSTOMER UPDATE THEIR VITEK MS KB VERSION TO KB (B)(4). SINCE THE EXPECTED IDENTIFICATION IS UNKNOWN IT IS POSSIBLE THAT THE SPECIES WAS NOT PRESENT IN THE VITEK MS KB (B)(4) OR (B)(4). AGAIN, THE CUSTOMER WOULD HAVE TO CONFIRM THE IDENTIFICATION WITH A REFERENCE METHOD, SUCH AS SEQUENCING. ROOT CAUSE ANALYSIS: FINE TUNING HAS DRIFTED UNDER THE VILINK ALERT TOOL CRITERIA. NON OPTIMAL SPOT PREPARATION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION WHILE TESTING AN ENVIRONMENTAL STRAIN FROM A PHARMA INDUSTRY LAB USING THE VITEK® MS INSTRUMENT (REFERENCE # 410895 , SERIAL # (B)(4)) WITH KNOWLEDGE BASE (KB) VERSION (B)(4) FOR INDUSTRY USE ONLY. LAB ID (B)(6) IDENTIFIED AS AEROMONAS VERONII, ISOLATED FROM EMPLOYEE CLOTHES COLLECTION. ALTERNATE METHOD: UNKNOWN. THE EXPECTED ORGANISM IDENTIFICATION IS UNKNOWN. THERE IS NO PATIENT HARM SINCE THIS WAS AN ENVIRONMENTAL STRAIN; THEREFORE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626927 VITEK® MS VITEK MS INSTRUMENT PEX BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1