BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11815902 · Received May 12, 2021

    Report

    Report Number
    9615754-2021-00161
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Report Date
    September 17, 2021
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    UDI-DI
    03573026359119
    PMA / PMN Number
    K162950
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN CHINA NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION AS STAPHYLOCOCCUS XYLOSUS, INSTEAD OF STAPHYLOCOCCUS SAPROPHYTICUS WHEN USING THE VITEK® MS SYSTEM (REF. 410895, SERIAL (B)(6) USING KNOWLEDGE BASE 3.2. THERE WAS NO PATIENT OR OPERATOR DEATH, NO PATIENT OR OPERATOR HARMED, NO INDIRECT HARM PATIENT REPORTED, NO PATIENT HARMED/TREATED INCORRECTLY. INVESTIGATION FIRST, THE INVESTIGATOR LOOKED AT THE DEVICE HISTORY RECORD. THERE IS NO CAPA, NOR NON-CONFORMITY ON VITEK MS LINKED WITH CUSTOMER COMPLAINT. THE INVESTIGATOR FOUND NO SIMILAR COMPLAINTS; NO ISOLATES OF STAPHYLOCOCCUS PSEUDOXYLOSUS WERE MISIDENTIFIED AS STAPHYLOCOCCUS XYLOSUS. FINE TUNING: THE FINE TUNING ANALYZER REPORT FOR THE LAST FINE TUNING DONE BEFORE THE IDENTIFICATION ISSUE HAS NOT BEEN PROVIDED. CONSEQUENTLY, THE INVESTIGATOR CANNOT CONFIRM THE FINE TUNING QUALITY/STATUS OF THE VITEK MS BEFORE THE IDENTIFICATION ISSUE. SPOT PREPARATION QUALITY: THE CUSTOMER¿S SPOT PREPARATION QUALITY WAS NOT OPTIMAL. THE CALIBRATOR ¿ALL PEAKS¿ VALUES WERE HETEROGENEOUS. KB REVIEW: THE EXPECTED ORGANISM IDENTIFICATION (STAPHYLOCOCCUS PSEUDOXYLOSUS) IS NOT PRESENT IN VITEK MS KB V3.0, V3.1 AND V3.2. SAMPLE DATA ANALYSIS: ANALYSIS OF MZML SAMPLE SHOWS THAT NUMBER OF ALL PEAKS ARE QUITE HETEROGENEOUS DURING THE ISSUE (BETWEEN 29 AND 113).THE MISIDENTIFICATION WAS OBTAINED WITH AN ACCEPTABLE IDENTIFICATION SCORE (BETWEEN 0.26 TO -0.15). FURTHER INVESTIGATION (TUF-GENE SEQUENCING) IDENTIFIED THE CUSTOMER STRAIN AS STAPHYLOCOCCUS PSEUDOXYLOSUS. THIS SPECIES IS NOT PRESENT IN ANY OF THE VITEK MS DATABASES, AND IT WAS JUST RECENTLY DESCRIBED (INT J SYST EVOL MICROBIOL 2019; 69:2208-2213). THE FOLLOWING SYSTEM LIMITATION IS MENTIONED 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.¿ ROOT CAUSE IS BELIEVED TO BE A COMBINATION OF FACTORS ¿ 1) SYSTEM LIMITATION (SPECIES NOT PRESENT IN THE VITEK MS KB V3.2); 2) NON-OPTIMAL SPOT PREPARATION; AND 3) NON-OPTIMAL FINE TUNING. CONCLUSION VITEK MS R&D DEPARTMENT HAS RECORDED THE CHANGE REQUEST (CR N°3955) IN ORDER TO ADD STAPHYLOCOCCUS PSEUDOXYLOSUS TO A FUTURE VITEK MS KNOWLEDGE BASE. LOCAL CUSTOMER SERVICE REQUESTED THE CUSTOMER PERFORM A NEW FINE TUNING AS WELL AS PROVIDE ADDITIONAL TRAINING MATERIALS TO THE CUSTOMER TO HELP IMPROVE THE SPOT PREPARATION TECHNIQUE. SERVICE ALSO PROVIDED INFORMATION REGARDING VITEK® PICKME¿ (REF 423551/ 423546). LASTLY THEY INDICATED TO THE CUSTOMER THAT THEY SHOULD PERFORM A NEW FINE TUNING ENSURING THAT ALL THE MANDATORY ACCEPTANCE CRITERIA ARE ACHIEVED BEFORE RELEASING THE INSTRUMENT FOR ROUTINE USE.

    Description of Event or Problem · 0

    INTENDED USE: THE VITEK® MS SYSTEM, REFERENCE 410895, IS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF STAPHYLOCOCCUS SAPROPHYTICUS AS STAPHYLOCOCCUS XYLOSUS WHEN USING THE VITEK® MS SYSTEM, REFERENCE 410895, SERIAL NUMBER (B)(4). A POSITIVE GRAM COCCUS SEPARATED FROM PATIENT WOUND SURFACE HAS BEEN IDENTIFIED AS STAPHYLOCOCCUS SAPROPHYTICUS WITH DNA SEQUENCING. BOTH STAPHYLOCOCCUS XYLOSUS AND STAPHYLOCOCCUS SAPROPHYTICUS ARE IN VITEK MS KB3.0 DATABASE. NO INFORMATION HAS BEEN PROVIDED REGARDING ANY POTENTIAL PATIENT IMPACT OF THE ORGANISM MISIDENTIFICATION. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710655 VITEK MS INSTRUMENT VITEK MS INSTRUMENT PEX BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1