BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 ANC ID TEST KIT

    MDR report key: 6605333 · Received June 1, 2017

    Report

    Report Number
    1950204-2017-00175
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Report Date
    July 11, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JSP
    UDI-DI
    03573026144364
    PMA / PMN Number
    K910666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A CLOSTRIDIUM SEPTICUM CAP SURVEY SAMPLE AS CLOSTRIDIUM CLOSTRIDIOFORME IN ASSOCIATION WITH THE VITEK® 2 ANC TEST KIT. AN INVESTIGATION WAS PERFORMED. THE BIOMÉRIEUX INTERNAL LYOPHILIZED CAP SAMPLE D-04 WAS RECONSTITUTED AND SUBBED ONTO ANAEROBIC CDC AGAR, WHICH WAS INCUBATED UNDER ANAEROBIC CONDITIONS FOR 24 HOURS, AND TESTED ON THREE DIFFERENT VITEK® 2 ANC LOTS. VITEK® MS TESTING WAS ALSO PERFORMED. ALL THREE CARD LOTS TESTED OBTAINED AN EXCELLENT ID (99%) OF C. SEPTICUM. THE VITEK® MS ALSO IDENTIFIED THE ORGANISM AS C. SEPTICUM, WITH A 99.9% CONFIDENCE VALUE. WHEN CUSTOMER LAB REPORTS WITH THE INCORRECT IDS OF C. CLOSTRIDIOFORME WERE EXAMINED, IT WAS NOTED THAT A "GRAM NEGATIVE" RESULT WAS ENTERED FOR OFFLINE TESTING INSTEAD OF "GRAM POSITIVE". THIS RESULTED IN C. CLOSTRIDIOFORME BEING IDENTIFIED INSTEAD OF C. SEPTICUM. IN SOME OF THESE CASES, THERE WAS ALSO ONE ATYPICAL NEGATIVE RESULT (BDFUC) WHEN COMPARED TO EXPECTED REACTION RESULTS FOR C. SEPTICUM. IN CONCLUSION THE VITEK® 2 ANC TEST KIT. PERFORMED AS EXPECTED AND NO FURTHER ACTION IS NECESSARY.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CAP SURVEY STRAIN CLOSTRIDIUM SEPTICUM AS CLOSTRIDIUM CLOSTRIDIFORME IN ASSOCIATION WITH THE VITEK® 2 ANAEROBIC AND CORYNEBACTERIA (ANC) IDENTIFICATION (ID) TEST KIT. UPON THE ADVICE OF BIOMÉRIEUX SUPPORT PERSONNEL, THE CUSTOMER REPEATED TESTING USING A SECOND SWAB; THE EXPECTED CAP ID OF CLOSTRIDIUM SEPTICUM WAS OBTAINED. 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 DIRECTLY ASSOCIATED WITH THE CAP SURVEY STRAIN. BIOMÉRIEUX INVESTIGATION WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387477 VITEK® 2 ANC ID TEST KIT VITEK® 2 ANC ID TEST KIT JSP BIOMERIEUX, INC 2440082403 03573026144364

    Patients

    Seq Age Sex Outcome Treatment
    1