BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN ID TEST KIT

    MDR report key: 7018925 · Received November 10, 2017

    Report

    Report Number
    1950204-2017-00376
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Report Date
    January 9, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF A KLEBSIELLA VARIICOLA API EDUCATIONAL SURVEY STRAIN AS KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE WHEN TESTING WITH THE VITEK® 2 GN ID TEST KIT . THE ORGANISM WAS SUBMITTED FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE ORGANISM WAS SUBBED, AND TESTED WITH GN CARDS FROM TWO CUSTOMER LOTS AND A RANDOM LOT , IN DUPLICATE. TESTING WAS ALSO PERFORMED WITH THE VITEK MS, AS WAS SEQUENCING OF THE GYRB GENE. TESTING ON ALL SIX (6) CARDS RESULTED IN AN EXCELLENT OR VERY GOOD ID OF K. PNEUMONIAE SSP PNEUMONIAE. VITEK MS 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 TWO 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 GN 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 A MISIDENTIFICATION RESULT FOR AN API EDUCATIONAL SURVEY STRAIN WHEN TESTING WITH VITEK® 2 GN ID TEST KIT (REF 21341), LOT 2410265203. VITEK® 2 IDENTIFIED THE STRAIN AS KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE. PER API, THE ISOLATE SHOULD HAVE BEEN KLEBSIELLA VARIICOLA. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT ASSOCIATED WITH THIS SURVEY ISOLATE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796429 VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX INC. 2410265203 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1