BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-YS08 TEST KIT

    MDR report key: 7033431 · Received November 15, 2017

    Report

    Report Number
    1950204-2017-00382
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Report Date
    May 10, 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 THE OCCURRENCE OF FALSE SUSCEPTIBLE FLUCONAZOLE RESULT FOR BIOLOGIE PROSPECTIVE CANDIDA NORVEGENSIS STRAIN IN ASSOCIATION WITH THE VITEK® 2 AST-YS08 TEST KIT. NO RETEST WAS PERFORMED FOR THIS SURVEY STRAIN. 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.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF FALSE SUSCEPTIBLE FLUCONAZOLE RESULT FOR BIOLOGIE PROSPECTIVE CANDIDA NORVEGENSIS STRAIN IN ASSOCIATION WITH THE VITEK® 2 AST-YS08 TEST KIT. NO RETEST WAS PERFORMED FOR THIS SURVEY STRAIN. 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 BIOLOGIE PROSPECTIVE SURVEY STRAIN. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812290 VITEK® 2 AST-YS08 TEST KIT VITEK® 2 AST-YS08 TEST KIT NGZ BIOMERIEUX, INC. 2880150203

    Patients

    Seq Age Sex Outcome Treatment
    1