BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 NH TEST CARD

    MDR report key: 6489449 · Received April 13, 2017

    Report

    Report Number
    1950204-2017-00117
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Report Date
    July 10, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    K842587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF A MISIDENTIFICATION OF (B)(6) (ATCC® 19424¿) AS NEISSERIA CINEREA IN ASSOCIATION WITH THE VITEK® 2 NH IDENTIFICATION TEST KIT (CARD). THE CUSTOMER SUBMITTED THE (B)(6) (ATCC® 19424¿) SAMPLE FOR INVESTIGATIONAL TESTING. THE INVESTIGATION INCLUDED TESTING OF THREE (3) NH ID CARD LOTS WITH THE CUSTOMER STRAIN AND THE INTERNAL BIOMÉRIEUX STRAIN: CUSTOMER LOT 245390220 (CL1) TESTED TWICE ON BOTH STRAINS. CUSTOMER LOT 2450185403 (CL2) TESTED TWICE ON BOTH STRAINS. RANDOM LOT 245398920 (RL) TESTED TWICE ON BOTH STRAINS. ISOLATES WERE SUBCULTURED AS INDICATED IN THE PACKAGE INSERT. THE INTERNAL STRAIN (ALL CARD LOTS) OBTAINED IDENTIFICATION TO (B)(6). THE CUSTOMER STRAIN (ALL CARD LOTS) OBTAINED IDENTIFICATION TO (B)(6). THE INVESTIGATION DID NOT REPRODUCE THE CUSTOMER RESULTS FOR THE CUSTOMER STRAIN NOR THE INTERNAL REFERENCE STRAIN WHATEVER THE LOT TESTED. AFTER COMPARISON OF BIOCHEMICAL PROFILES BETWEEN EXPECTED RESULTS AND THE PROFILE OBTAINED BY THE CUSTOMER (IDENTIFICATION TO NEISSERIA CINEREA), THE INVESTIGATION OBSERVED TWO (2) DISCREPANT TESTS (FALSE NEGATIVE ARGA AND APPA). AN INCREASED NUMBER OF ATYPICAL NEGATIVE RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. AN INCREASED NUMBER OF ATYPICAL NEGATIVE REACTIONS MAY HAVE BEEN CAUSED BY LEAVING THE ISOLATE OUT OF CO2 FOR AN EXTENDED PERIOD OF TIME. SINCE (B)(6) IS A FASTIDIOUS SPECIES, IT NEEDS TO BE CONTAINED IN A CO2 ENVIRONMENT TO RETAIN ROBUSTNESS. IF THIS SPECIES IS LEFT OUTSIDE OF CO2 FOR EXTENDED PERIODS, IT WILL BECOME LESS ROBUST AND THEREFORE LESS REACTIVE IN THE NH ID CARD. THE INVESTIGATION CONCLUDED THE VITEK® 2 NH ID CARD IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF A DISCREPANT RESULT ASSOCIATED WITH VITEK® 2 NH TEST KIT. THE CUSTOMER PERFORMED TWO METHODS : THEY USED THE STRAIN AFTER 18-24 HOURS OF INCUBATION AND AFTER 48 HOURS OF INCUBATION. FOR EACH INCUBATION, THE RESULTS OF THE ATCC STRAIN WERE NON-CONFORMING. THE RESULT OBTAINED WAS NEISSERIA CINEREA INSTEAD OF NEISSERIA (B)(6) THE NEISSERIA (B)(6) ATCC 19424 HAS NOT TO BE TESTED SYSTEMATICALLY WITH THE NH TEST KIT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. THE STRAIN IN QUESTION IS AN INTERNAL QUALITY CONTROL SAMPLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271996 VITEK® 2 NH TEST CARD VITEK® 2 NH TEST CARD JTO BIOMERIEUX, INC 21346 245390220

    Patients

    Seq Age Sex Outcome Treatment
    1