BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 10992717 · Received December 11, 2020

    Report

    Report Number
    9615754-2020-00191
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Report Date
    December 11, 2020
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN PERFORMED BY ANALYZING THE CUSTOMER¿S DATA. FINE TUNING: ACCORDING TO THE COMPLAINT, A FINE TUNING WAS PERFORMED (B)(6) 2020 JUST BEFORE TESTING WAS PERFORMED AND IT CONFORMED TO SPECIFICATIONS. SPOT PREPARATION QUALITY: THE CUSTOMER¿S SPOT PREPARATION QUALITY WAS NOT OPTIMAL. THE CALIBRATOR AND SAMPLE ¿ALL PEAKS¿ VALUES ARE QUITE HETEROGENEOUS. IN CASE OF OPTIMAL SPOT PREPARATION, THE ¿ALL PEAKS¿ VALUES OF CALIBRATORS SPECTRA SHOULD BE HOMOGENEOUS. KNOWLEDGE BASE (KB) REVIEW: THE EXPECTED IDENTIFICATION IS PSEUDOMONAS MONTEILII, WHICH IS PRESENT IN THE VITEK MS KNOWLEDGE BASE (B)(4). SAMPLE DATA ANALYSIS: REPROCESSING OF THE CUSTOMER DATA WITH VITEK MS KB (B)(4) SHOWED THAT THERE IS A HETEROGENEITY OF THE ¿ALL PEAKS¿ NUMBER; IT VARIED BETWEEN 67 TO 117. HOWEVER, IT SEEMED TO NOT BE THE CAUSE OF THE ISSUE AS ALL TESTS GAVE THE SAME MISIDENTIFICATION TO PSEUDOMONAS PUTIDA. REPROCESSING OF THE CUSTOMER DATA WITH NEW VITEK MS KB (B)(4) IN DEVELOPMENT OBTAINS THE SAME RESULTS AS VITEK MS KB (B)(4). NO IMPROVEMENT OBSERVED. REPROCESSING OF THE CUSTOMER DATA WITH SARAMIS (B)(4) (RUO MODE) DEMONSTRATED : THE SPECTRA ACQUIRED SEEMS TO BE CLOSED TO PSEUDOMONAS PUTIDA. IT IS DIFFICULT TO SEPARATE THIS STRAIN OF PSEUDOMONAS MONTEILII FROM OTHER PSEUDOMONAS SPECIES. PSEUDOMONAS MONTEILII DSM 14164 HAS NOT BEEN TESTED DURING OUR KNOWLEDGE BASE DEVELOPMENT. THE PSEUDOMONAS MONTEILII CLASS WAS BUILT WITH 8 SPECTRA / 3 STRAINS. THIS IS LOWER THAN FOR PSEUDOMONAS PUTIDA (58 SPECTRA - 27 STRAINS). IT COULD EXPLAIN THE RESULTS OBSERVED BY THE CUSTOMER. BIOMÉRIEUX ASSESSED THE RISK ASSOCIATED WITH THIS ISSUE AND DETERMINED THAT THE OVERALL RISK IS IRRELEVANT. A CHANGE REQUEST WAS OPENED BY R&D TO IMPROVE THESE TWO CLASSES WITH NEW SPECTRA ACQUISITIONS IN ORDER TO INCREASE THE DISCRIMINANT POWER OF THE KB FOR THESE SPECIES. ADDITIONALLY. IT WAS RECOMMENDED THAT LOCAL CUSTOMER SERVICE CHECK SAMPLE PREPARATION WITH THE CUSTOMER AND PROVIDE CUSTOMER TRAINING MATERIALS TO IMPROVE THEIR SPOT PREPARATION TECHNIQUE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF AN ATCC® PSEUDOMONAS MONTEILII STRAIN AS PSEUDOMONAS PUTIDA SPECIES IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT ¿ (REF. 410895), SERIAL NUMBER: (B)(4). THE CUSTOMER STATED THAT THE PSEUDOMONAS MONTEILII WAS A QUALITY CONTROL STRAIN FROM AN ATCC® SOURCE. THEY OBTAINED AN IDENTIFICATION AS PSEUDOMONAS PUTIDA (WITH 99.9% OF CONFIDENCE), TWICE. THEY ASSERT THE SPOT QUALITY WAS GOOD AND 1UL WAS ADDED. THE CUSTOMER IS AN INDUSTRY FACILITY AND THE STRAIN TESTED IS A QUALITY CONTROL SAMPLE, THUS NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456752 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1