BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS

    MDR report key: 10285620 · Received July 16, 2020

    Report

    Report Number
    9615754-2020-00116
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Report Date
    July 16, 2020
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    UDI-DI
    03573026359119
    PMA / PMN Number
    DEN130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING MISIDENTIFICATION OF MORAXELLA ATLANTAE AS EIKENELLA CORRODENS WHILE TESTING A QC SAMPLE PROVIDED BY THE CHINA MINISTRY OF PUBLIC HEALTH USING THE VITEK® MS INSTRUMENT (REFERENCE # 410895). SERIAL NUMBER OF INSTRUMENT WAS NOT PROVIDED. VITEK® MS RESULTS: KNOWLEDGE BASE (KB): KB VERSION : (B)(4) (CLI) SINGLE CHOICE TO EIKENELLA CORRODENS. VITEK MS RUO MODE - KB (B)(4) : MORAXELLA ATLANTAE. THERE IS NO PATIENT ASSOCIATED WITH THIS QC SAMPLE; THEREFORE, THERE IS NO 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
    745242 VITEK MS VITEK MS INSTRUMENT PEX BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1