BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT

    MDR report key: 6793974 · Received August 15, 2017

    Report

    Report Number
    1950204-2017-00268
    Event Type
    Malfunction
    Date Received
    August 15, 2017
    Report Date
    December 4, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JST
    UDI-DI
    03573026144357
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CAPNOCYTOPHAGA SPECIES (QUALITY CONTROL SAMPLE) IN ASSOCIATION WITH THE VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE INTENDED IDENTIFICATION TO CAPNOCYTOPHAGA CARNIMORSUS WAS CONFIRMED ON VITEK® MS V3 (KNOWLEDGE BASE V3.0). ON VITEK® 2 (V7.01) NH CARDS, TWO (2) CARDS OF THE CUSTOMER LOT (CL : 2450285403) FROM CBA SUBCULTURE AND TWO (2) CARDS OF A RANDOM LOT (RL : 2450288203) FROM PVX SUBCULTURE WERE TESTED. THESE TESTS ON THE CL GAVE A VERY GOOD IDENTIFICATION TO NEISSERIA ELONGATA 94% FROM CBA SUBCULTURES AND A GOOD IDENTIFICATION TO NEISSERIA GONORRHOEAE 89% FROM PVX SUBCULTURES. ON THE RL, UNIDENTIFIED RESULTS WERE OBTAINED FROM BOTH SUBCULTURES. THE CUSTOMER MISIDENTIFICATION WAS REPRODUCED ON THE CUSTOMER LOT #2450285403 WHATEVER THE MEDIA USED WHILE THE RANDOM LOT #2450288203 GAVE NO IDENTIFICATION. VITEK® 2 NH TEST KIT LOT #2450285403 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING. THIS IS AN ATYPICAL STRAIN.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CAPNOCYTOPHAGA SPECIES (QUALITY CONTROL SAMPLE) IN ASSOCIATION WITH THE VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT. FIVE VITEK® 2 NH ID (5) TESTS WERE PERFORMED SIMULTANEOUSLY FROM THE SAME ISOLATE; ALL FIVE TESTS PROVIDED A RESULT OF LOW DISCRIMINATION BETWEEN NEISSERIA AND MORAXELLA SPECIES. 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. THE QUALITY CONTROL SAMPLE WAS NOT DIRECTLY ASSOCIATED WITH ANY PATIENT. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574762 VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT VITEK® 2 NH ID TEST KIT JST BIOMERIEUX, INC 2450285403 03573026144357

    Patients

    Seq Age Sex Outcome Treatment
    1