BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK®2 GN TEST KIT

    MDR report key: 7079137 · Received December 4, 2017

    Report

    Report Number
    1950204-2017-00425
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Report Date
    February 19, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 GN TEST KIT (REFERENCE 21341). THE CUSTOMER HAD A QC ORGANISM ENTEROBACTER HORMAECHEI ATCC® 700323¿ THAT FAILED DURING STREAMLINED QC FOR TWO TRIES, AND THE 2ND ORGANISM STENOTROPHOMONAS MALTOPHILIA ATCC® 17666¿ FAILED THE FIRST TIME BUT PASSED THE 2ND TIME ON THE UREA WELL. THE TEST WAS RUN A THIRD TIME AND WAS SUCCESSFUL. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE BIOMÉRIEUX E. HORMAECHEI ATCC 700323 AND S. MALTOPHILIA ATCC 17666 INTERNAL QUALITY CONTROL STRAINS WERE SUB-CULTURED, AND TESTING INCLUDED VITEK® 2 GN CARDS FROM THE CUSTOMER LOT (2410243403) AND FROM A RANDOM LOT (2410069103), IN DUPLICATE FOR EACH STRAIN. ALL EIGHT (8) GN CARDS TESTED RESULTED IN THE EXPECTED NEGATIVE UREA REACTIONS, WITHOUT QC DEVIATIONS FOR EITHER STRAIN. WITHOUT CUSTOMER STRAINS OR RAW DATA IT IS NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THESE ATYPICAL REACTIONS. VITEK 2 GN CARDS ARE PERFORMING AS EXPECTED FOR THESE STRAINS AND NO FURTHER ACTION IS REQUIRED. VITEK 2 GN LOT 2410243403 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK®2 GN TEST KIT (REFERENCE 21341). THE CUSTOMER HAD A QC ORGANISM ENTEROBACTER HORMAECHEI ATCC® 700323¿ THAT FAILED DURING STREAMLINED QC DURING TWO TRIES, AND THE 2ND ORGANISM STENOTROPHOMONAS MALTOPHILIA ATCC® 17666¿ FAILED THE FIRST TIME BUT PASSED THE 2ND TIME ON THE UREA WELL. THE TEST WAS RUN A THIRD TIME AND WAS SUCCESSFUL. THERE WAS NO PATIENT ASSOCIATED WITH THIS CASE, TESTING WAS PERFORMED ON A QUALITY CONTROL SAMPLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858444 VITEK®2 GN TEST KIT VITEK®2 GN TEST KIT LQM BIOMERIEUX INC. 2410243403 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1