BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK®2 GRAM NEGATIVE TEST KIT

    MDR report key: 6916718 · Received October 5, 2017

    Report

    Report Number
    1950204-2017-00324
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Report Date
    January 8, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES HAD NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED VITEK®2 GRAM NEGATIVE TEST KIT (REFERENCE 21341). THE CUSTOMER REPORTED THE NANOSPHERE PCR INSTRUMENT IDENTIFIED AN ORGANISM AS NOT KLEBSIELLA PNUEMONIAE, AND VITEK® 2 IDENTIFIED THE ORGANISMS AS K. PNUEMONIAE. NANOSPHERE INDICATED TO THE CUSTOMER THAT THE CORRECT RESULT IS LIKELY KLEBSIELLA VARIICOLA. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED USING THE ISOLATE SUBMITTED BY THE CUSTOMER. THE ORGANISM WAS SUBBED, AND TESTING INCLUDED TWO CUSTOMER LOTS AND A RANDOM LOT OF VITEK 2 GN ID CARDS, RUN IN DUPLICATE. VITEK® MS WAS PERFORMED, AS WAS SEQUENCING OF THE GYRB GENE. TESTING ON ALL SIX CARDS RESULTED IN AN EXCELLENT OR VERY GOOD ID OF K. PNEUMONIAE SSP PNEUMONIAE. VITEK MS ALSO GAVE AN IDENTIFICATION OF K. PNEUMONIAE, WITH A 99.9% CONFIDENCE LEVEL. SINCE K. PNEUMONIAE AND K. VARIICOLA ARE VERY CLOSELY RELATED SPECIES, 16S SEQUENCING CANNOT DIFFERENTIATE BETWEEN THE 2 SPECIES. THEREFORE, GYRB SEQUENCING WAS PERFORMED. UNFORTUNATELY, GYRB SEQUENCING OF THIS ISOLATE SHOWED A 97% IDENTITY MATCH WITH BOTH K. PNEUMONIAE AND K. VARIICOLA. THEREFORE, THE FINAL IDENTIFICATION OF THIS ISOLATE IS K. PNEUMONIAE/K. VARIICOLA. K. VARIICOLA IS AN UNCLAIMED SPECIES THAT IS NOT IN THE VITEK 2 GN ID CARD KNOWLEDGEBASE. ACCORDING TO THE PRODUCT INFORMATION GUIDE, TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED VITEK®2 GRAM NEGATIVE TEST KIT (REFERENCE 21341). THE CUSTOMER REPORTED THE NANOSPHERE PCR INSTRUMENT IDENTIFIED THE ORGANISMS AS NOT K. PNUEMONIAE AND THE VITEK® CARDS IDENTIFIED THE ORGANISMS AS K. PNUEMONIAE. NANOSPHERE IS TELLING THE CUSTOMER THAT THE RESULT IS LIKELY K. VARIICOLA. THE CUSTOMER DID NOT REPEAT THE TESTING ON THE VITEK® INSTRUMENT. THE ISOLATE IS BEING SENT OUT FOR IDENTIFICATION TESTING. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697673 VITEK®2 GRAM NEGATIVE TEST KIT VITEK®2 GRAM NEGATIVE TEST KIT LQM BIOMERIEUX INC. 21341 2410185403 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1