BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN ID TEST KIT

    MDR report key: 6869904 · Received September 15, 2017

    Report

    Report Number
    1950204-2017-00308
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Report Date
    March 21, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE IN ASSOCIATION WITH VITEK® 2 GN ID TEST KIT (REF 21341), LOT 2410142103. THE CUSTOMER SUBMITTED THE STRAIN FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE ORGANISM WAS SUBCULTURED ON CBA MEDIUM. TWO DIFFERENT COLONIES WERE OBSERVED AND TESTED WITH 16S SEQUENCING, WHICH RESULTED IN AN IDENTIFICATION TO THE SPECIES K. PNEUMONIAE FOR BOTH COLONIES. ON VITEK 2 (V7.01) , ONE (1) GN CARD OF THE CUSTOMER LOT (CL: 2410142103) AND ONE (1) CARD OF A RANDOM LOT (RL: 2410100103), WERE TESTED FROM THE MASS ON CBA AND CPSE SUBCULTURES. THOSE TESTS GAVE AN EXCELLENT IDENTIFICATION TO K. PNEUMONIAE SSP PNEUMONIAE ON BOTH LOTS TESTED, AND BOTH MEDIA USED. COMPLEMENTARY TESTS WERE ALSO PERFORMED FOR EACH OF THE COLONIES FROM CBA SUBCULTURE ON VITEK 2 (V7.01) GN CARDS, ONE (1) CARD OF THE CUSTOMER LOT (CL : 2410142103) AND ONE (1) CARD OF ANOTHER RANDOM LOT (RL : 2410367203). AN EXCELLENT IDENTIFICATION TO K. PNEUMONIAE SSP PNEUMONIAE WAS OBTAINED ON BOTH LOTS TESTED FOR THE FIRST COLONY, AND ONLY ON THE RL FOR THE SECOND COLONY (UNIDENTIFIED ORGANISM ON CL). THE IDENTIFICATION EXPECTED WAS CONFIRMED WITH VITEK MS V3 (KNOWLEDGE BASE V3.0) : EXCELLENT IDENTIFICATION TO K. PNEUMONIAE (99.9%). THE CUSTOMER MISIDENTIFICATION TO K. OXYTOCA WAS NOT REPRODUCED IN-HOUSE. THE VITEK 2 GN CARD PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE IN ASSOCIATION WITH VITEK® 2 GN ID TEST KIT (REF 21341), LOT 2410142103. THE CUSTOMER REPORTED THAT VITEK® 2 IDENTIFIED A URINARY ISOLATE AS KLEBSIELLA OXYTOCA WITH 99% PROBABILITY. WITH THE API 20E STRIP, THE ISOLATE WAS IDENTIFIED AS KLEBSIELLA PNEUMONIA. THE CUSTOMER PERFORMED INDOLE TESTING, WHICH WAS NEGATIVE. THE CUSTOMER ALSO TESTED A BLOOD CULTURE ISOLATE FROM THE SAME PATIENT WITH VITEK® 2 AND API 20E. BOTH TESTING METHODS IDENTIFIED THE ISOLATE AS KLEBSIELLA PNEUMONIA. CUSTOMER STATED THAT PATIENT RESULTS WERE AFFECTED. NO WRONG RESULTS WERE REPORTED TO A PHYSICIAN, NO INCORRECT TREATMENT WAS GIVEN, AND THE PATIENT WAS NOT HARMED. THERE WAS A DELAY GREATER THAN 24 HOURS IN REPORTING PATIENT RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649090 VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX INC. 2410142103 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1