BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 7138351 · Received December 21, 2017

    Report

    Report Number
    1950204-2017-00471
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Report Date
    March 19, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQM
    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 REPORTED A MISIDENTIFICATION OF AN ACINETOBACTER BAUMANNII STRAIN AS KLEBSIELLA OXYTOCA IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT (LOT 2410283103). THE CUSTOMER SUBMITTED THE STRAIN FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE INTENDED IDENTIFICATION TO A. BAUMANNII COMPLEX WAS CONFIRMED USING VITEK MS V3 (KNOWLEDGE BASE V3.0). ON VITEK 2 (V7.01) ONE GN CARD OF THE CUSTOMER LOT (CL : 2410283103) AND ONE GN CARD OF A RANDOM LOT (RL : 2410142103) FROM CBA AND TSA SUBCULTURES WERE TESTED. THE TESTS GAVE AN EXCELLENT IDENTIFICATION TO A. BAUMANNII COMPLEX 99% ON BOTH CARD LOTS WHATEVER THE MEDIA USED. THE CUSTOMER'S MISIDENTIFICATION TO K. OXYTOCA WAS NOT REPRODUCED IN-HOUSE WHATEVER THE LOT AND THE MEDIA USED. IN CONCLUSION, THE VITEK 2 GN CARD PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF AN ACINETOBACTER BAUMANNII STRAIN AS KLEBSIELLA OXYTOCA IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT (LOT 2410283103). THE CUSTOMER STATED THE STRAIN WAS FROM HBRE (HIGHLY RESISTANT EMERGING BACTERIA) SCREENING ON CHROMID® CARBA SMART AGAR AND SUBCULTURED ON TRYPCASE SOY AGAR. THE CUSTOMER REPORTED THAT K. OXYTOCA WAS TWICE IDENTIFIED WITH THE GN CARD FROM TSA. THE SAME MEDIA PLATE WAS SENT TO A REFERENCE LAB WHERE THE ORGANISM WAS IDENTIFIED AS ACINETOBACTER BAUMANNII WITH VITEK® 2 AND BRUCKER METHODS. THE CUSTOMER RETESTED THE STRAIN FROM COS, AND THE RESULT WAS K.OXYTOCA (99%). THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX 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
    918913 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST KIT LQM BIOMERIEUX, INC 2410283103

    Patients

    Seq Age Sex Outcome Treatment
    1