BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-YS07 TEST KIT

    MDR report key: 7104475 · Received December 11, 2017

    Report

    Report Number
    1950204-2017-00443
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Report Date
    May 10, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    NGZ
    PMA / PMN Number
    K133952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF FALSE SUSCEPTIBLE FLUCYTOSINE RESULT (MIC = 4¿G/ML) FOR CANDIDA NORVEGENSIS EEQ BIOLOGIE PROFICIENCY SAMPLE IN ASSOCIATION WITH THE VITEK® 2 AST-YS07 TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED THAT INCLUDED TESTING FOR BOTH FLUCONAZOLE (FLU) AND FLUCYTOSINE (FCT) RESULTS ON VITEK® 2 AST-YS07 CARDS WITH A STRAIN OF CANDIDA NORVEGENSIS FROM THE BIOLOGIE PROSPECTIVE SURVEY (MYCOLOGY 2017- SAMPLE 3A). ID TESTING : IDENTIFICATION WAS CONFIRMED TO CANDIDA NORVEGENSIS ON YST CARD (LOT 2430356103) AST TESTING: · REFERENCE METHOD TO DETERMINE THE INTENDED RESULT FOR FLUCONAZOLE AND FLUCYTOSINE: BROTH MICRODILUTION, METHOD USED TO DEVELOP THE FORMULARIES "FLU01N" / "FCT01N" (IN AST-YS07 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 -YS07 ON VITEK 2 V7.01 THREE (3) VITEK 2 AST-YS07 CARD LOTS WERE TESTED FROM SABOURAUD DEXTROSE AGAR (SDA). VITEK 2 GAVE THE FOLLOWING RESULTS: **FLU MIC = 16 MG/L I ON THE THREE (3) LOTS TESTED **FCT MIC = 4 MG/L S ON TWO (2) LOTS , 8 MG/L I ON THE THIRD LOT. THE VITEK 2 RESULTS ARE WITHIN ESSENTIAL AGREEMENT WITH THE REFERENCE MIC WITHIN +/- 1 DOUBLING DILUTION. NOTE: ACCORDING TO FSCA 2509 (RELEASED APRIL 2015), FCT RESULTS FROM AST-YS07 CARDS (FCT01N FORMULATION) SHOULD NOT BE REPORTED FOR ANY ORGANISM. CONCLUSION: -WE DUPLICATED THE CUSTOMER RESULTS ON AST-YS07 CARDS (MIC FLU=16 MG/L I AND FCT MIC=4 MG/L S). -]THE VITEK 2 AST-YS07 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)(4) REPORTED THE OCCURRENCE OF FALSE SUSCEPTIBLE FLUCYTOSINE RESULT (MIC = 4¿G/ML) FOR CANDIDA NORVEGENSIS EEQ BIOLOGIE PROFICIENCY SAMPLE IN ASSOCIATION WITH THE VITEK® 2 AST-YS07 TEST KIT. THE EXPECTED RESULT WAS "RESISTANT"; NO EXPECTED MIC WAS PROVIDED FOR THE PROFICIENCY SAMPLE. THE VITEK® 2 AST-YS07 FLUCYTOSINE RESULT MIC = 4 IS SUSCEPTIBLE (S) USING EUCAST BREAKPOINTS, BUT RESISTANT (R) USING CLSI BREAKPOINTS. 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 PROFICIENCY SAMPLE. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885932 VITEK® 2 AST-YS07 TEST KIT VITEK® 2 AST-YS07 TEST KIT NGZ BIOMERIEUX, INC. 2870235203

    Patients

    Seq Age Sex Outcome Treatment
    1