BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 ANC TEST KIT

    MDR report key: 6634029 · Received June 12, 2017

    Report

    Report Number
    1950204-2017-00192
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Report Date
    July 10, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JSP
    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 (95%) 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. A COMPARISON OF CUSTOMER CARD REACTION RESULTS FOR C. PERFRINGENS AGAINST EXPECTED REACTION RESULTS FOR C. SEPTICUM SHOWED TEN ATYPICAL POSITIVE REACTIONS (LEUA, DGLU, DMNE, DMAL, SAC, NAG, URE, ARG, PVATE, PHOS) AND TWO ATYPICAL NEGATIVE REACTIONS (BGALI, BDFUC) WHICH LED TO THE MISIDENTIFICATION. IT SHOULD BE NOTED THAT THE D-04 SAMPLE CONTAINED TWO ORGANISMS: C. SEPTICUM AND S. AUREUS. THE PRESENCE OF S. AUREUS IN THE SAMPLE, IN ADDITION TO THE C. SEPTICUM, MAY HAVE RESULTED IN THE MISIDENTIFICATION ON THE ANC CARDS. THE 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.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A CLOSTRIDIUM SEPTICUM CAP SURVEY SAMPLE AS CLOSTRIDIUM CLOSTRIDIOFORME (95%) IN ASSOCIATION WITH THE VITEK® 2 ANC TEST KIT. THE CUSTOMER STATED THE SECOND CAP SAMPLE SWAB GAVE A CORRECT IDENTIFICATION OF CLOSTRIDIUM SEPTICUM. THERE WAS NO PATIENT INVOLVEMENT AS THIS ISOLATE WAS A SURVEY SAMPLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414209 VITEK® 2 ANC TEST KIT VITEK® 2 ANC TEST CARD JSP BIOMERIEUX, INC 2440138103

    Patients

    Seq Age Sex Outcome Treatment
    1