BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-YS07 TEST KIT

    MDR report key: 5949551 · Received September 14, 2016

    Report

    Report Number
    1950204-2016-00122
    Event Type
    Malfunction
    Date Received
    September 14, 2016
    Report Date
    January 30, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    NGZ
    PMA / PMN Number
    K133817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BIOMERIEUX INVESTIGATION WAS INITIATED DUE TO A FALSE SUSCEPTIBLE FLUCONAZOLE RESULT ON THE AST-YS07 CARD FOR A CANDIDA ALBICANS ISOLATE, COMPARED TO ETEST® AND REFERENCE LAB RESULTS (RESISTANT). THE CUSTOMER ALSO OBSERVED THE SAME ISSUE ON VORICONAZOLE. THE REFERENCE METHOD WAS PERFORMED TO DETERMINE THE INTENDED RESULTS FOR FLUCONAZOLE AND VORICONAZOLE BMD (BROTH MICRODILUTION), COMPARED WITH VITEK® 2 (V6.01) AND AST-YS07 CARDS. CATEGORY INTERPRETATIONS BASED ON VITEK® 2 BREAKPOINTS WERE: FLUCONAZOLE: S</=8- S-DD 16-32 R>/=64. VORICONAZOLE: S</=1- S-DD 2 R>/=4. TWO DIFFERENT LOTS OF AST- YS07 CARDS WERE TESTED: THE CUSTOMER LOT 287394320 AND A RANDOM LOT 287389420. TEST RESULTS OBTAINED WITH BMD: - FLUCONAZOLE REFERENCE MIC >64MG/L RESISTANT. -VORICONAZOLE REFERENCE MIC>16 MG/L RESISTANT. RESULTS CONFIRMED THOSE OBTAINED BY THE REFERENCE INSTITUTE. ON VITEK® 2, THE RESULTS OBTAINED ON BOTH LOTS TESTED WERE FLU MIC <= 1MG/L S AND VRC MIC <=0.125MG/L S. THE INVESTIGATION DUPLICATED THE CUSTOMER RESULTS. THE INVESTIGATION CONCLUDED THE SUBMITTED ISOLATE HAS AN ATYPICAL BIOCHEMICAL PROFILE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF A FALSE SUSCEPTIBLE FLUCONAZOLE RESULT FOR CANDIDA ALBICANS IN ASSOCIATION WITH THE VITEK® 2 AST-YS07 TEST KIT. ETEST FLUCONAZOLE PROVIDED A RESISTANT RESULT. REPEAT TESTING OBTAINED THE SAME RESPECTIVE RESULTS. THE CUSTOMER REPORTS A DELAY IN REPORTING DUE TO THE ADDITIONAL TESTING PERFORMED. THE PATIENT WAS TREATED WITH A DIFFERENT ANTIMYCOTICUM. THE CUSTOMER SENT THE PATIENT STRAIN TO A REFERENCE LABORATORY. THE REFERENCE LABORATORY OBTAINED RESULTS OF RESISTANT TO FLUCONAZOLE (TEST METHOD UNKNOWN), CONFIRMING THE VITEK® 2 AST-YS07 RESULT TO BE DISCREPANT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603211 VITEK® 2 AST-YS07 TEST KIT VITEK® 2 AST-YS07 TEST KIT NGZ BIOMERIEUX, INC 287394320

    Patients

    Seq Age Sex Outcome Treatment
    1