BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11815771 · Received May 12, 2021

    Report

    Report Number
    9615754-2021-00160
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE CUSTOMER COMPLAINT, BIOMERIEUX CONDUCTED AN INTERNAL INVESTIGATION. REVIEW OF THE CUSTOMER¿S FINE-TUNING DATA FOUND THE INSTRUMENT¿S FINE-TUNING WAS AT THE ACCEPTABLE LIMIT WHEN THE IDENTIFICATION TESTING WAS PERFORMED. REVIEW OF THE CUSTOMER¿S DATA SHOWED THE CUSTOMER¿S SPOT PREPARATION QUALITY WAS NOT OPTIMAL, THE CALIBRATOR ¿ALL PEAKS¿ VALUES WERE HETEROGENEOUS. THE MISIDENTIFICATION RESULT OBTAINED A LOW IDENTIFICATION SCORE (-0.31) 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 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 CAUSE OF THE CUSTOMER¿S MISIDENTIFICATION WAS NON-OPTIMAL SPOT PREPARATION.

    Description of Event or Problem · 0

    AN INDUSTRY CLIENT FROM UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION RESULT IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT (REF. 410895, SERIAL NUMBER: (B)(4)) AND KNOWLEDGE BASE (KB) VERSION 3.2 IND WHEN TESTING AN ENVIRONMENTAL ISOLATE. THE CLIENT PERFORMED TESTING USING A COLONY CULTURED ON TRYPTIC SOY AGAR (TSA) THAT WAS INCUBATED AT 35°C FOR 18 HOURS. THE VITEK® MS IDENTIFIED THE ISOLATE AS CLOSTRIDIUM SPOROGENES. THE CLIENT STATED THE CLOSTRIDIUM SPOROGENES IDENTIFICATION DID NOT ALIGN WITH GRAM STRAIN RESULT OF GRAM-POSITIVE COCCI. THE CLIENT THEN INOCULATED A SECOND TSA PLATE AND TESTED THE ISOLATE USING 16S RRNA GENE SEQUENCING, WHICH IDENTIFIED THE ENVIRONMENTAL ISOLATE AS STAPHYLOCOCCUS GENUS. AS IT WAS AN ENVIRONMENTAL ISOLATE FROM AN INDUSTRY CLIENT, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706928 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1