BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS INSTRUMENT

    MDR report key: 11702245 · Received April 21, 2021

    Report

    Report Number
    9615754-2021-00089
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Report Date
    December 1, 2021
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN CANADA NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF BACILLUS SPECIES AS PREVOTELLA ORIS IN ASSOCIATION WITH THEIR VITEK® MS INSTRUMENT (REF. 410895 / (B)(6)). INVESTIGATION THE INVESTIGATOR REVIEWED THE BIOMÉRIEUX COMPLAINT DATABASE FOR MISIDENTIFICATIONS DUE TO SYSTEM LIMITATION. SINCE JANUARY 2016, EIGHT COMPLAINTS HAVE BEEN RECORDED FOR PAENIBACILLUS SPP MISIDENTIFIED AS PREVOTELLA ORIS : THREE CASES WHERE PAENIBACILLUS ETHERI IS MISIDENTIFIED AS PREVOTELLA ORIS; ONE CASE WITH P. ODORIFER MISIDENTIFIED AS PREVOTELLA ORIS; AND FOUR CASES WITH PAENIBACILLUS SPP MISIDENTIFIED AS P. ORIS. FINE TUNING: ACCORDING TO VILINK ALERT TOOL CRITERIA, FINE TUNING WAS SUFFICIENT DURING CUSTOMER¿S TESTS. SPOT PREPARATION: THE CUSTOMER'S SPOT PREPARATION DOES NOT APPEAR TO BE OPTIMAL. THE SAMPLE ¿ALL PEAKS¿ VALUES ARE HOMOGENEOUS, HOWEVER THE CALIBRATOR ¿ALL PEAKS¿ VALUES ARE HETEROGENEOUS. KNOWLEDGE BASE REVIEW: INVESTIGATION CONFIRMED THAT P. ETHERI IS NOT PRESENT IN VITEK MS INSTRUMENT KB V3.2. SAMPLE DATA ANALYSIS: THE MISIDENTIFICATIONS WERE OBTAINED WITH A LOW SCORE AND TWO OF THEM (-0.14 AND -0.28) ARE NEAR THE LIMIT VALUE OF -0.4 FOR GIVING A "NO IDENTIFICATION" RESULT. THE CUSTOMER SUBMITTED A PORTION OF THEIR SAMPLE TO BIOMÉRIEUX FOR TESTING. THE BIOMÉRIEUX QUALITY CONTROL LABORATORY REPRODUCED THE MISIDENTIFICATION. INVESTIGATORS IDENTIFIED PREVOTELLA ORIS FOR THE FIVE TESTS MADE. HOWEVER, BIOMÉRIEUX R&D IDENTIFIED THE CUSTOMER STRAIN TO PAENIBACILLUS ETHERI WITH PARTIAL 16-S SEQUENCING. CONCLUSION: ROOT CAUSE IS A KNOWN SYSTEM LIMITATION - SPECIES NOT PRESENT IN THE VITEK MS KB V3.2. PAENIBACILLUS ETHERI IS NOT PRESENT IN THE VITEK MS KB V3.2. THE FOLLOWING SYSTEM LIMITATION IS INCLUDED IN THE VITEK MS V3.2 KNOWLEDGE BASE USER MANUAL REF. 161150-924-A:¿* 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.¿ TWO PRODUCT IMPROVEMENTS HAVE BEEN REQUESTED: (B)(4) WILL ADD PAENIBACILLUS ETHERI TO A FUTURE VITEK® MS KNOWLEDGE BASE VERSION AND (B)(4) WILL IMPROVE THE WAY THE KNOWLEDGE BASE HANDLES PREVOTELLA ORIS SPECTRA. LOCAL CUSTOMER SERVICE PROVIDED THE CUSTOMER WITH ADDITIONAL TRAINING MATERIALS TO HELP IMPROVE THEIR SPOT PREPARATION TECHNIQUE. CUSTOMER SERVICE ALSO PROVIDED INFORMATION REGARDING VITEK® PICKME¿ (REF 423551/ (B)(6)) TO HELP WITH SAMPLE SPOT PREPARATION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) A NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF BACILLUS SPECIES AS PREVOTELLA ORIS WITH THE VITEK MS SYSTEM, REFERENCE 410895, SERIAL NUMBER (B)(4). BIOCHEMICAL TESTS HAVE BEEN PERFORMED BY THE CUSTOMER TO CONFIRM THE ORGANISM AND THE GRAM STAINING. NO INFORMATION HAS BEEN PROVIDED REGARDING THE ANY PATIENT IMPACT DUE TO THE MISIDENTIFICATION. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597987 VITEK® MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown