BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN ID TEST KIT

    MDR report key: 6997631 · Received November 2, 2017

    Report

    Report Number
    1950204-2017-00363
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Report Date
    November 2, 2017
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUBMITTED THE PATIENT ISOLATE AND AN INTERNAL INVESTIGATION WAS COMPLETED. THE SUBMITTED ISOLATE WAS SUBCULTURED, AND TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS WITH VITEK® 2 GN ID CARDS FROM THE CUSTOMER AND RANDOM LOTS, IN DUPLICATE, API 20E, VITEK MS, AND 16S SEQUENCING. THE RESULTS WERE AS FOLLOWS: -VITEK® 2 GN ID: ALL FOUR GN CARDS TESTED GAVE ACCEPTABLE IDENTIFICATIONS OF ESCHERICHIA COLI . -API 20E: LOW DISCRIMINATION IDENTIFICATION. -VITEK® MS: FINAL IDENTIFICATION OF ESCHERICHIA COLI, WITH A 99 % IDENTITY MATCH. -16S SEQUENCING: FINAL IDENTIFICATION OF ESCHERICHIA COLI, WITH A 99 % IDENTITY MATCH. THE CUSTOMER'S REPORTED VITEK® GN CARD IDENTIFICATION OF E. COLI WAS CORRECT FOR THIS STRAIN. VITEK® 2 CARDS PERFORMED AS EXPECTED FOR THIS ISOLATE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF SHIGELLA SONNEI IN ASSOCIATION WITH VITEK® 2 GN ID TEST KIT (REF 21341), LOT 2410127203. THE ORGANISM WAS IDENTIFIED AS SHIGELLA SONNEI BY BIOFIRE GI PATHOGEN PANEL. VITEK® 2 GAVE AN IDENTIFICATION OF ESCHERICHIA COLI. THE CUSTOMER SENT THE ISOLATE TO THE STATE REFERENCE LAB FOR SEROTYPING, WHICH CONFIRMED THE ORGANISM AS SHIGELLA SONNEI. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777464 VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX, INC. 2410127203 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1