BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS INSTRUMENT

    MDR report key: 12464012 · Received September 13, 2021

    Report

    Report Number
    9615754-2021-00249
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Report Date
    November 3, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN CANADA NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF MORAXELLA SPP. AS KOCURIA RHIZOPHILA IN ASSOCIATION WITH THE VITEK® MS (REF (B)(6), SERIAL (B)(6)). INVESTIGATION; FINE TUNING: STATUS GOOD AT THE TIME OF ACQUISITION. ACCORDING TO THE VILINK ALERT TOOL CRITERIA, FINE TUNING STATUS WAS AT THE LIMIT DURING THE TESTS MADE BETWEEN (B)(6) 2021. THE FINE TUNING INDICATORS ACCEPTANCE CRITERIA COULD BE AFFECTED BY THE NON-OPTIMAL FINE TUNING MADE PRIOR TO THE MISIDENTIFICATION AND BY THE QUALITY OF THE CALIBRATOR SPOT PREPARATION. IN THESE CONDITIONS, THE VILINK ALERT TOOL MIGHT NOT REFLECT THE REAL STATUS OF THE SYSTEM. GOOD FINE TUNING AND GOOD CALIBRATOR SPOT PREPARATION ARE A PREREQUISITE FOR MONITORING THE SYSTEM USING THE VILINK ALERT TOOL. SPOT PREPARATION QUALITY: THE INVESTIGATOR ANALYZED DATA PROVIDED FROM THE CUSTOMER TO DETERMINE THE QUALITY OF THEIR SPOT PREPARATION. THE CALIBRATOR ¿ALL PEAKS¿ VALUES WERE HETEROGENEOUS. KB REVIEW: BASED ON THE INFORMATION PROVIDED, THE EXPECTED IDENTIFICATION HAS BEEN DEFINED AS MORAXELLA SPP WHICH IS NOT PRESENT IN VITEK® MS KB V3.2 AT A GENUS LEVEL. KNOWLEDGE BASE V3.2 INCLUDES THE FOLLOWING STRAINS: .M. CATARRHALIS, M. CUNICULI, M. NONLIQUEFACIENS, M. OSLOENSIS, M. OVIS, AND M. LACUNTA. SAMPLE DATA ANALYSIS: BY REPROCESSING THE CUSTOMER DATA WITH VITEK MS KB V3.2, SPECTRA LED TO NO IDENTIFICATION RESULT. THE MISIDENTIFICATION REPORTED BY THE CUSTOMER WAS NOT CONFIRMED WITH THE DATA PROVIDED. CONCLUSION: THE INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT THEY OBTAINED A MISIDENTIFICATION DUE TO THE COMBINATION OF A SYSTEM LIMITATION (SPECIES OUT OF KB V3.2) ALONG WITH BAD QUALITY SPECTRA (LINKED TO A NON-OPTIMAL SPOT PREPARATION OR/AND NON-OPTIMAL FINE TUNING). IN ADDITION, THE FOLLOWING SYSTEM LIMITATION IS MENTIONED IN THE VITEK® MS V3.0 KNOWLEDGE BASE USER MANUAL REF. (B)(6): ¿ 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.¿ 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 (B)(6)) TO HELP WITH SAMPLE SPOT PREPARATION. LASTLY, SERVICE SUGGESTED THE CUSTOMER PERFORM A NEW FINE TUNING THAT ENSURES ALL OF THE MANDATORY ACCEPTANCE CRITERIA ARE MET. SINCE JANUARY 2016 THERE HAVE BEEN NO SIMILAR COMPLAINTS. NO ISOLATE OF MORAXELLA SPP WAS MISIDENTIFIED AS KOCURIA RHIZOPHILA.

    Description of Event or Problem · 1

    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. DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF MORAXELLA SPP. AS KOCURIA RHIZOPHILA IN ASSOCIATION WITH THE VITEK® MS (REF 410895, SERIAL (B)(4)). THE CUSTOMER REPORTED THAT THE VITEK® MS OBTAINED A RESULT OF KOCURIA RHIZOPHILA (72%). THE ISOLATE WAS SENT TO A REFERENCE LABORATORY WHERE IT WAS IDENTIFIED AS MORAXELLA SPP. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361817 VITEK® MS INSTRUMENT VITEK® MS INSTRUMENT QBN 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1