BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-YS08 TEST KIT

    MDR report key: 7045836 · Received November 20, 2017

    Report

    Report Number
    1950204-2017-00401
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Report Date
    May 11, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    NGZ
    PMA / PMN Number
    K133817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED IN RESPONSE TO A CUSTOMER IN (B)(6) REPORTING FALSE INTERMEDIATE FLUCONAZOLE RESULTS FOR A CANDIDA NORVEGENSIS EXTERNAL QUALITY CONTROL (EEQ) STRAIN IN ASSOCIATION WITH THE VITEK® 2 AST-YS08 TEST KIT. THE RESULT WAS FLUCONAZOLE : MIC = 16, INTERMEDIATE. THE EXPECTED RESULT WAS RESISTANT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED THAT INCLUDED TESTING FOR BOTH FLUCONAZOLE (FLU) AND FLUCYTOSINE (FCT) RESULTS WITH A STRAIN OF CANDIDA NORVEGENSIS ON VITEK® 2 AST-YS08 CARDS. THIS STRAIN IS FROM A BIOLOGIE PROSPECTIVE SURVEY (MYCOLOGY 2017- SAMPLE 3A). ID TESTING : IDENTIFICATION WAS CONFIRMED TO CANDIDA NORVEGENSIS ON VITEK 2 YST ID CARD (LOT 2430356103). AST TESTING: · REFERENCE METHOD TO DETERMINE THE INTENDED RESULT FOR FLUCONAZOLE AND FLUCYTOSINE: BROTH MICRODILUTION, METHOD USED TO DEVELOP THE FORMULARIES "FLU02N" / "FCT02N" (IN AST-YS08 CARD). · FLU MIC = 16 MG/L INTERMEDIATE · FCT MIC = 8 MG/L INTERMEDIATE INTERPRETATION ACCORDING TO VITEK 2 BREAKPOINTS IN V7.01 : FDA 2009 BREAKPOINTS FOR CANDIDA / FLUCONAZOLE S </=8 - I 16-32 - R >/=64. FDA 2012 BREAKPOINTS FOR CANDIDA / FLUCYTOSINE : S </=4 - I 8-16 - R >/=32. NOTE: FOR ANTIFUNGALS, ESSENTIAL AGREEMENT BETWEEN VITEK® 2 CARD AND REFERENCE METHOD MICS IS +/- 2 DOUBLING DILUTIONS. · PRODUCTS & SYSTEM INCRIMINATED: -AST -YS08 ON VITEK 2 V7.01 THREE (3) VITEK 2 AST-YS08 LOTS WERE TESTED FROM SABOURAUD DEXTROSE AGAR (SDA). VITEK 2 GAVE THE FOLLOWING RESULTS ON THE THREE (3) LOTS TESTED: **FLU MIC = 8 MG/L SUSCEPTIBLE **FCT MIC = 4 MG/L SUSCEPTIBLE THE VITEK 2 RESULTS ARE WITHIN ESSENTIAL AGREEMENT WITH THE REFERENCE MIC WITHIN +/- 1 DOUBLING DILUTION. CONCLUSION: -THE CUSTOMER RESULTS WERE DUPLICATED ON THE AST-YS08 CARDS (MIC FLU= 8 MG/L S AND FCT MIC=4 MG/L S). -THE VITEK 2 AST-YS08 CARDS PERFORM AS INTENDED. THE VITEK 2 VALUES ARE WITHIN ESSENTIAL AGREEMENT WITH THE REFERENCE RESULTS OBTAINED IN BMD. -THE REFERENCE MIC FOR BOTH FLUCONAZOLE AND FLUCYTOSINE ARE IN THE MIDDLE OF THE BREAKPOINTS, SO THE STRAIN CAN BE SUSCEPTIBLE OR RESISTANT WITHIN +/- 2 DOUBLING DILUTIONS. -->BORDERLINE STRAIN.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED FALSE SUSCEPTIBLE FLUCYTOSINE RESULTS AND FALSE INTERMEDIATE FLUCONAZOLE RESULTS FOR A CANDIDA NORVEGENSIS EXTERNAL QUALITY CONTROL (EEQ) STRAIN IN ASSOCIATION WITH THE VITEK® 2 AST-YS08 TEST KIT. THE RESULTS WERE: FLUCYTOSINE : MIC = 4 SUSCEPTIBLE. THE EXPECTED RESULT WAS RESISTANT. FLUCONAZOLE : MIC = 16, INTERMEDIATE. THE EXPECTED RESULT WAS RESISTANT. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO AN EXTERNAL QUALITY CONTROL SAMPLE. AN INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824840 VITEK® 2 AST-YS08 TEST KIT VITEK® 2 AST-YS08 TEST KIT NGZ BIOMERIEUX, INC 2880150203

    Patients

    Seq Age Sex Outcome Treatment
    1