BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11821493 · Received May 13, 2021

    Report

    Report Number
    9615754-2021-00162
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Report Date
    May 13, 2021
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE CUSTOMER COMPLAINT BIOMERIEUX CONDUCTED AN INTERNAL INVESTIGATION. THE ISOLATE WAS NOT SUBMITTED FOR INVESTIGATION AND THEREFORE COULD NOT BE TESTED. REVIEW OF THE CUSTOMER'S FINE-TUNING DATA FOUND ONE MANDATORY CRITERIA WAS NOT ACHIEVED. REVIEW OF THE CUSTOMER'S DATA SHOWED THE CUSTOMER'S SPOT PREPARATION QUALITY WAS OPTIMAL, THE CALIBRATOR "ALL PEAKS" VALUES WERE HOMOGENEOUS. THE MISIDENTIFICATION RESULT OBTAINED A LOW IDENTIFICATION SCORE (-0.35) WHICH IS NEAR THE ACCEPTABLE LIMIT FOR GIVING AN "IDENTIFICATION" RESULT VS. A "NO IDENTIFICATION" RESULT (0.4). THE MISIDENTIFICATION RESULT ALSO HAD A LOW NUMBER OF PEAKS (32) WHICH IS NEAR THE ACCEPTABLE LIMIT FOR GIVING AN "IDENTIFICATION" RESULT OR A "NO IDENTIFICATION" RESULT (30 PEAKS). THIS CAN ALSO BE CAUSED BY NON-OPTIMAL SPOT PREPARATION OF THE SAMPLE STRAIN. THE VITEK® MS V3.2 KNOWLEDGE BASE USER MANUAL REF. 161150-924-A STATES THE FOLLOWING SYSTEM LIMITATION: "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." THE INVESTIGATION DETERMINED THE MOST PROBABLE ROOT CAUSES OF THE CUSTOMER'S MISIDENTIFICATION WERE DUE TO INSTRUMENT FINE-TUNING AND KNOWLEDGE BASE SYSTEM LIMITATION.

    Description of Event or Problem · 0

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING A MISIDENTIFICATION RESULT IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT (REF. 410895, SERIAL NUMBER (B)(4)) AND KNOWLEDGE BASE (KB) V3.2 WHEN TESTING A PATIENT ISOLATE. THE CUSTOMER CULTURED THE PATIENT ISOLATE ON BLOOD AGAR AND INCUBATED AT 30°C WITHOUT CARBON DIOXIDE PRIOR TO TESTING ON THE VITEK® MS INSTRUMENT. THE CUSTOMER TESTED THE ISOLATE FOUR (4) TIMES; THE FOLLOWING RESULTS WERE OBTAINED. NO IDENTIFICATION - THREE (3) TIMES SINGLE CHOICE MYCOBACTERIUM INTRACELLULARE - ONE (1) TIME THE ISOLATE WAS ALSO TESTED USING THE BRUKER MALDI-TOF AND HAIN GENOTYPING TEST METHODS, BOTH METHODS IDENTIFIED THE ISOLATE AS UNCLASSIFIED MYCOBACTERIA. THE CUSTOMER CONFIRMED THE MISIDENTIFICATION RESULT HAD NO ADVERSE IMPACT TO THE PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713559 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1