BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-YS08 TEST KIT

    MDR report key: 7182865 · Received January 11, 2018

    Report

    Report Number
    1950204-2018-00020
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    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

    THE CORRECT PMA/510(K) NUMBER IS K133952.

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED IN RESPONSE TO A CUSTOMER FROM (B)(6) REPORTING A FALSE SUSCEPTIBLE FLUCYTOSINE RESULT FOR A CANDIDA NORVENGENSIS EXTERNAL QUALITY CONTROL SAMPLE (EEQ BIOLOGIE PROSPECTIVE) IN ASSOCIATION WITH THE VITEK® 2 AST-YS08 TEST KIT. 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 FROM (B)(6) REPORTED A FALSE SUSCEPTIBLE FLUCYTOSINE RESULT FOR A CANDIDA NORVENGENSIS EXTERNAL QUALITY CONTROL SAMPLE (EEQ BIOLOGIE PROSPECTIVE) IN ASSOCIATION WITH THE VITEK® 2 AST-YS08 TEST KIT. THE AST-YS08 CARD RESULTS WERE: FLUCONAZOL MIC = 16 INTERMEDIATE, FLUCYTOSINE MIC = 4 SUSCEPTIBLE. THE CUSTOMER REPORTED THAT THE EXPECTED RESULTS WERE RESISTANT FOR BOTH FLUCONAZOL AND FLUCYTOSINE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27394 VITEK® 2 AST-YS08 TEST KIT VITEK® 2 AST-YS08 TEST KIT NGZ BIOMERIEUX, INC 2880297203

    Patients

    Seq Age Sex Outcome Treatment
    1