BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 ANC TEST KIT

    MDR report key: 6677740 · Received June 29, 2017

    Report

    Report Number
    1950204-2017-00206
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Report Date
    June 29, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JSP
    PMA / PMN Number
    K910666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMÉRIEUX INTERNAL LYOPHILIZED CAP SAMPLE D-04 WAS RECONSTITUTED AND SUBBED ONTO ANAEROBIC CDC AGAR, WHICH WAS INCUBATED UNDER ANAEROBIC CONDITIONS FOR 24 HR. TESTING WAS PERFORMED ON 3 DIFFERENT ANC LOTS. VITEK® MS TESTING WAS ALSO PERFORMED. ON ALL 3 CARD LOTS TESTED, AN EXCELLENT ID (99%) OF C. SEPTICUM WAS OBTAINED. VITEK® MS ALSO IDENTIFIED THE ORGANISM AS C. SEPTICUM, WITH A 99.9% CONFIDENCE VALUE. A COMPARISON OF CUSTOMER CARD REACTION RESULTS FOR C. PERFRIGENS AGAINST EXPECTED REACTION RESULTS FOR C. SEPTICUM SHOWED 10 ATYPICAL POSITIVE REACTIONS (LEUA, DGLU, DMNE, DMAL, SAC, NAG, URE, ARG, PVATE, PHOS) AND 2 ATYPICAL NEGATIVE REACTIONS (BGALI, BDFUC) WHICH LED TO THE MISIDENTIFICATION. IT SHOULD BE NOTED THAT THE D-04 SAMPLE CONTAINED 2 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. 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. WHEN CUSTOMER LAB REPORTS WITH THE INCORRECT ID OF C. CHAUVOEI WERE EXAMINED, IT WAS NOTED THAT THE OFFLINE GRAM TESTING RESULT WAS NOT ENTERED, AND THERE WAS ALSO 1 ATYPICAL NEGATIVE REACTION (BDFUC) WHEN COMPARED TO EXPECTED RESULTS FOR C. SEPTICUM. VITEK® 2 ANC TEST CARDS ARE PERFORMING 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 PERFRIGENS IN ASSOCIATION WITH THE VITEK® 2 ANC TEST KIT. THE CUSTOMER REPORTED THAT BOTH SURVEY SWABS WERE IDENTIFIED AS CLOSTRIDIUM PERFRIGENS. THE EXPECTED CAP SURVEY IDENTIFICATION WAS CLOSTRIDIUM SEPTICUM. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS A SURVEY SAMPLE. THE CUSTOMER SUBMITTED LAB REPORTS FROM THE TESTING OF BOTH SWABS AND THE CAP SUMMARY REPORT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458436 VITEK® 2 ANC TEST KIT VITEK® 2 ANC TEST CARD JSP BIOMERIEUX, INC 2440138103

    Patients

    Seq Age Sex Outcome Treatment
    1