BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS

    MDR report key: 6866448 · Received September 14, 2017

    Report

    Report Number
    3002769706-2017-00278
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    PMA / PMN Number
    DEN130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6) REPORTED A DISCREPANT ORGANISM IDENTIFICATION IN ASSOCIATION WITH THE VITEK MS SYSTEM. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. PROBLEM DESCRIPTION: VITEK MS RESULT - SINGLE CHOICE TO STREPTOCOCCUS SUIS. OTHER IDENTIFICATION METHOD: VITEK 2 GP ID TEST KIT - LOW DISCRIMINATION BETWEEN STREPTOCOCCUS MITIS, STREPTOCOCCUS ORALIS AND STREPTOCOCCUS SANGUINIS. SEQUENCING (REFERENCE METHOD) - STREPTOCOCCUS PARASUIS (REPORT NOT PROVIDED BY THE CUSTOMER). EXPECTED IDENTIFICATION - STREPTOCOCCUS PARASUIS. CONCLUSION: AS KEY INFORMATION (E.G. MZML DTA FILES) WAS NOT PROVIDED, IT WAS NOT POSSIBLE FOR THE SUPPORT TEAM TO INVESTIGATE AND DEFINE THE ROOT CAUSE OF THIS ISSUE; HOWEVER, BASED IN THE INFORMATION RECEIVED (REFERENCE METHOD RESULT) THE MOST PROBABLE IDENTIFICATION IS STREPTOCOCCUS PARASUIS. THIS SPECIES IS NOT INCLUDED IN THE VITEK MS KNOWLEDGE BASE (KB) (B)(4). THE REPORTED ISSUE FALLS UNDER THE LIMITATION INDICATED IN THE KB USER MANUAL REF. 161150-556-B FOR VITEK MS CLINICAL USE (B)(4): "TESTING OF SPECIES NOT FOUND IN THE DATABASE MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION." THIS LIMITATION IS NOT INDICATED IN THE KB USER MANUAL REF. 161150-137-D FOR VITEK MS CLINICAL USE (B)(4) (IN USE AT CUSTOMER SITE). FOR THIS REASON, AN URGENT PRODUCT SAFETY NOTICE (FSCA 3305 - VITEK MS (B)(4) SYSTEM LIMITATIONS) WAS PUBLISHED ON FEBRUARY 2017 IN ORDER TO INFORM CUSTOMERS ABOUT THIS SYSTEM LIMITATION.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF STREPTOCOCCUS MITIS AS STREPTOCOCCUS SUIS IN ASSOCIATION WITH THE VITEK® MS V2.0. THE CUSTOMER REPORTED THAT THE VITEK® MS GAVE SEVERAL RESULTS OF THE ORGANISM BEING A STREPTOCOCCUS SUIS. SEQUENCING WAS PERFORMED ON THE ISOLATE WHICH IDENTIFIED STREPTOCOCCUS PARASUIS. AN EXTERNAL LABORATORY IDENTIFIED THE ISOLATE AS STREPTOCOCCUS MITIS. THE CUSTOMER REPORTED THAT AN INCORRECT RESULT WAS REPORTED TO A PHYSICIAN, HOWEVER, THE PHYSICIAN BELIEVED IN THE RESULT FROM THE EXTERNAL LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT AND NO DELAY IN REPORTING RESULTS. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646184 VITEK® MS VITEK® MS PEX BIOMERIEUX, SA 410895

    Patients

    Seq Age Sex Outcome Treatment
    1