BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 5851698 · Received August 5, 2016

    Report

    Report Number
    1950204-2016-00086
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Report Date
    July 8, 2016
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    K962609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED DUE TO VITEK® 2 GN ID MISIDENTIFICATION OF SALMONELLA SER PARATYPHI A AS SHIGELLA GROUP. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. INVESTIGATION DETAILS: THE ISOLATE WAS SUBCULTURED AND TESTING INCLUDED TWO (2) VITEK 2 GN ID CARDS FROM THE SAME LOT TESTED BY THE CUSTOMER, TWO (2) CARDS FROM A RANDOM LOT AND API 20E. THE FOUR VITEK 2 GN ID CARDS GAVE EXCELLENT IDENTIFICATION CALLS OF ESCHERICHIA COLI. THE API 20E PROVIDED IDENTIFICATION TO SALMONELLA SER PARATYPHI A WITH A 99.5% CONFIDENCE LEVEL. IT SHOULD BE NOTED THAT, WHEN AN IDENTIFICATION OF SHIGELLA / SALMONELLA IS MADE BY VITEK 2 GN ID CARDS, AN ANALYSIS MESSAGE OF "CONFIRM BY SEROLOGICAL TESTS" IS GIVEN ON THE LAB REPORT. THE INVESTIGATION CONCLUDED THIS IS AN ATYPICAL STRAIN FOR THE VITEK 2 GN KNOWLEDGE BASE.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A CUSTOMER IN UNITED STATES NOTIFIED BIOMERIEUX OF A MISIDENTIFICATION ASSOCIATED WITH THE VITEK 2 GN TEST KIT (B)(4) INVOLVING A BLOOD CULTURE. THE CUSTOMER REPORTED USING THE VITEK 2 GN TEST KIT THAT IDENTIFIED THE ORGANISM AS ONE OF THE SHIGELLA GROUP. HOWEVER, SEROLOGY WAS POSITIVE FOR SALMONELLA POLYVALENT ANTISERA. THE CUSTOMER INDICATED THERE WAS NO NEGATIVE IMPACT TO THE PATIENT OR ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501486 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST KIT JTO BIOMERIEUX, INC 241374840

    Patients

    Seq Age Sex Outcome Treatment
    1