BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT

    MDR report key: 7134140 · Received December 20, 2017

    Report

    Report Number
    1950204-2017-00469
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Report Date
    March 12, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JXB
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED A MISIDENTIFICATION OF CANDIDA GLABRATA IN ASSOCIATION WITH THE VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT. THE CUSTOMER SUBMITTED THE ISOLATE FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE SUBMITTED ISOLATE WAS SUBCULTURED AND TESTED WITH YST CARDS FROM THE CUSTOMER'S LOT AND A RANDOM LOT, IN DUPLICATE. VITEK MS AND API 20 CAUX WERE ALSO PERFORMED. ALL FOUR YST CARDS TESTED RESULTED IN EXCELLENT AND VERY GOOD IDENTIFICATIONS OF C. ALBICANS. VITEK MS RESULTED IN AN IDENTIFICATION OF C. ALBICANS WITH A 99.9% CONFIDENCE VALUE. API 20 CAUX ALSO RESULTED IN VERY GOOD IDENTIFICATION OF C. ALBICANS. THE FINAL IDENTIFICATION OF THE SUBMITTED ISOLATE IS C. ALBICANS. ONE LAB REPORT WAS SUBMITTED SHOWING A GOOD IDENTIFICATION OF C. LAURENTII WITH FIVE ATYPICAL POSITIVE REACTIONS (BNAG, LACA, GGT, IARAA, ESC) FOR AN IDENTIFICATION OF C. ALBICANS ACCORDING TO THE YST KNOWLEDGE BASE. AN INCREASED NUMBER OF ATYPICAL REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON-RECOMMENDED MEDIA OR OTHER USER SET UP ERRORS. THE VITEK 2 YST CARDS PERFORMED AS EXPECTED FOR THIS SUBMITTED STRAIN AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CANDIDA GLABRATA IN ASSOCIATION WITH THE VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT. THE INITIAL YST ID TEST IDENTIFIED THE STRAIN AS LOW DISCRIMINATION BETWEEN CANDIDA ALBICANS AND CANDIDA FAMATA. UPON REPEAT TESTING WITH A FRESH ISOLATE, THE RESULT WAS UNIDENTIFIED. A THIRD ATTEMPT OBTAINED CANDIDA CIFERRII. THE CUSTOMER SENT THE STRAIN TO A REFERENCE LABORATORY; TESTING VIA MALDI-TOF (BRUKER AND VITEK® MS) OBTAINED CANDIDA GLABRATA COMPLEX. THE CUSTOMER STATED THE FINAL YEAST IDENTIFICATION OF CANDIDA GLABRATA COMPLEX WAS REPORTED TO THE PHYSICIAN BASED ON REFERENCE LABORATORY IDENTIFICATION. NO INCORRECT IDENTIFICATION WAS REPORTED TO THE PHYSICIAN; THERE WAS NO ADVERSE IMPACT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912380 VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT VITEK® 2 YST ID TEST KIT JXB BIOMERIEUX, INC 2430398223

    Patients

    Seq Age Sex Outcome Treatment
    1