BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 7625612 · Received June 21, 2018

    Report

    Report Number
    1950204-2018-00232
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Report Date
    September 18, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STRAIN WAS ISOLATED FROM RAW CHICKEN NUGGETS. ALTHOUGH THE EVENT INVOLVES A FOOD PRODUCT, IT IS BEING REPORTED AS THE VITEK 2 GN TEST KIT IS ALSO USED IN CLINICAL APPLICATIONS.

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF SALMONELLA ENTERICA AS SHIGELLA SPECIES IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. AN INVESTIGATION WAS PERFORMED. THE CUSTOMER'S SUBMITTED STRAINS WERE SUBCULTURED AND TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS WITH GN CARDS FROM TWO RANDOM LOTS (2410545203, 2410454103) IN DUPLICATE, AS WELL AS THE VITEK MS. THE CUSTOMER'S LOT OF GN CARDS (2410196103) EXPIRED 10JUN2018 BEFORE THE ISOLATES WERE RECEIVED FOR INVESTIGATION. 911648: TWO GN CARDS RESULTED IN SLASHLINE IDENTIFICATIONS OF SHIGELLA GROUP AND TWO CARDS RESULTED IN LOW DISCRIMINATION IDENTIFICATIONS OF SHIGELLA GROUP/E. COLI. 911649: ALL FOUR GN CARDS RESULTED IN LOW DISCRIMINATION IDENTIFICATIONS OF SHIGELLA GROUP/E. COLI. 911650: ALL FOUR GN CARDS RESULTED IN LOW DISCRIMINATION IDENTIFICATIONS OF SHIGELLA GROUP/E. COLI. THE VITEK MS RESULTED IN THE FINAL IDENTIFICATIONS OF SALMONELLA GROUP WITH A 99% CONFIDENCE VALUE FOR ALL THREE ISOLATES, DUPLICATING THE CUSTOMER'S REPORTED MISIDENTIFICATION. A REVIEW OF THE CUSTOMER'S SHIGELLA GROUP REACTIONS, DEMONSTRATED TEN ATYPICAL NEGATIVE REACTIONS (PROA, DMAL, ODC, DMAN, SUCT, TYRA, CIT, AGAL, DSOR, PHOS) FOR AN IDENTIFICATION OF SALMONELLA ENTERICA ACCORDING TO THE GN KNOWLEDGE BASE. AN INCREASED NUMBER OF ATYPICAL NEGATIVE RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY OR AN ATYPICAL STRAIN. NOTE: ANY IDENTIFICATION OF SALMONELLA/SHIGELLA SHOULD BE CONFIRMED WITH ANOTHER METHOD SUCH AS SEROLOGY. THE GN LAB REPORT PRINTS THE MESSAGE "CONFIRM BY SEROLOGICAL TESTS" FOR ANY IDENTIFICATION OF SALMONELLA OR SHIGELLA.

    Description of Event or Problem · 1

    A CUSTOMER IN CANADA REPORTED A MISIDENTIFICATION OF SALMONELLA ENTERICA AS SHIGELLA SPECIES IN ASSOCIATION WITH THE VITEK 2 GN TEST KIT (LOT 2410196103). THE GN CARD IDENTIFIED THE STRAIN AS SHIGELLA GROUP (88%), BUT IT WAS ALSO IDENTIFIED AS SALMONELLA ENTERICA BY PCR AND A REFERENCE LABORATORY. THE CUSTOMER DID NOT PROVIDE PATIENT INFORMATION. THERE IS NO INDICATION OR REPORT TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466171 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST KIT LQM BIOMERIEUX, INC. 2410196103 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1