BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT - 410895

    MDR report key: 11916167 · Received June 1, 2021

    Report

    Report Number
    9615754-2021-00172
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Report Date
    August 4, 2021
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN GERMANY NOTIFIED BIOMÉRIEUX OF OBTAINING AN IDENTIFICATION OF A STRICT ANAEROBIC PREVOTELLA WHEN TESTING AN AEROBIC BLOOD CULTURE BOTTLE USING THE VITEK® MS (REF. (B)(6); SERIAL #(B)(6)). ORGANISM WAS IDENTIFIED WITH 99.9% CONFIDENCE LEVEL TO PREVOTELLA ORIS, WHICH IS A STRICT ANAEROBIC BACTERIA, WHILE TESTING AN AEROBIC BLOOD CULTURE BOTTLE. REPEAT TESTING RESULT WAS THE SAME. THE CUSTOMER QUESTIONED THE IDENTIFICATION BECAUSE THE SAMPLE CAME FROM AN AEROBIC BLOOD CULTURE BOTTLE AND P. ORIS ARE ANAEROBIC GRAM NEGATIVE RODS. RESULTS ARE CONSISTENT WITH POSSIBLE IDENTIFICATION AS A BRUCELLA SPP. INVESTIGATION: THE INVESTIGATOR REVIEWED PREVIOUS COMPLAINT REPORTS FOR SIMILAR MISIDENTIFICATIONS. SINCE JANUARY 2016, ONLY ONE COMPLAINT HAS BEEN RECORDED REGARDING THE MISIDENTIFICATION OF PAENIBACILLUS SPP AS PREVOTELLA ORIS. THERE ARE NO CAPAS, NOR NON-CONFORMITIES FOR VITEK MS LINKED WITH CUSTOMER 'S COMPLAINT. FINE TUNING: ACCORDING TO THE VILINK ALERT TOOL CRITERIA, NO FINE-TUNING WAS NEEDED ON EITHER VITEK MS INSTRUMENT DURING TESTS PERFORMED ON (B)(6) 2021. PREVIOUS FINE-TUNING WAS COMPLETED ON (B)(6) 2021, AND APPEARED ADEQUATE. SPOT PREPARATION QUALITY: THE CALIBRATOR ¿ALL PEAKS¿ VALUES ARE QUITE HETEROGENEOUS, WHICH IS TYPICALLY EXPLAINED BY A NON-OPTIMAL SPOT PREPARATION OF THE CALIBRATOR STRAIN (CULTURE, SPOT, DIFFERENT OPERATOR, OPERATOR SKILLS). KB REVIEW: NO REFERENCE METHOD WAS USED CONFIRM THE EXPECTED IDENTIFICATION, SO THE ACTUAL ORGANISM IDENTIFICATION REMAINS UNKNOWN. SAMPLE DATA ANALYSIS: THE MISIDENTIFICATION RESULTS WERE OBTAINED WITH LOW IDENTIFICATION SCORE (BETWEEN -0.01 TO -0.34) WHICH IS NEAR THE ACCEPTABLE LIMIT FOR GIVING AN ¿IDENTIFICATION¿ RESULT OR A ¿NO IDENTIFICATION¿ RESULT (-0.40). FURTHER INVESTIGATION IS NEEDED TO FIND THE CAUSE OF THE MISIDENTIFICATION ISSUE, AND SEQUENCING OF THE STRAIN SHOULD BE COMPLETED TO CONFIRM THE EXPECTED IDENTIFICATION. THE NEXT STEP WOULD BE TO REQUEST THE CUSTOMER SUBMIT THE STRAIN TO BIOMÉRIEUX; HOWEVER, THERE IS A POTENTIAL SAFETY RISK (BLS3), THUS STRAIN RETURN CANNOT BE ORGANIZED. CONSEQUENTLY, NO FURTHER INVESTIGATION IS POSSIBLE. IMPACT: THERE WERE NO PATIENT OR OPERATOR DEATH, NO PATIENT OR OPERATOR HARMED, NO INDIRECT HARM PATIENT REPORTED, NO PATIENT HARMED/TREATED INCORRECTLY. ROOT CAUSE REMAINS UNKNOWN. THE FOLLOWING SYSTEM LIMITATION IS MENTIONED IN THE VITEK MS V3.2 KNOWLEDGE BASE USER MANUAL REF. (B)(4): ¿ 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 SERVICE PROVIDED THE CUSTOMER WITH ADDITIONAL TRAINING MATERIALS TO HELP IMPROVE SPOT PREPARATION TECHNIQUE (VIDEO, TRAINING ). THEY ALSO PROPOSED THE CUSTOMER USE VITEK® PICKME (REF (B)(4)) FOR IMPROVED SPOT QUALITY.

    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 AN IDENTIFICATION OF A STRICT ANAEROBIC PREVOTELLA WHEN TESTING AN AEROBIC BLOOD CULTURE BOTTLE USING THE VITEK MS, REFERENCE 410895, SERIAL NUMBER : #(B)(4). THE CUSTOMER OBTAINED AN ORGANISM IDENTIFICATION WITH 99.9% CONFIDENCE LEVEL TO PREVOTELLA ORIS, WHICH IS A STRICT ANAEROBIC BACTERIA, WHILE TESTING AN AEROBIC BLOOD CULTURE BOTTLE. REPEAT TESTING CONFIRMED THIS IDENTIFICATION. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN, AND NO PATIENT IMPACT HAS BEEN REPORTED BY THE CUSTOMER AS A RESULT OF THE DISCREPANCY. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808690 VITEK MS INSTRUMENT - 410895 VITEK MS INSTRUMENT - 410895 QBN BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1