BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7388933 · Received April 2, 2018

    Report

    Report Number
    1950204-2018-00124
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    JXB
    UDI-DI
    03573026131937
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CANDIDA AURIS AS CANDIDA HAEMULONII IN ASSOCIATION WITH THE VITEK® 2 YST ID TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER SUBMITTED TWO (2) ISOLATES. BOTH ISOLATES WERE SUBBED, AND TESTING INCLUDED BOTH VITEK 2 YST CUSTOMER CARD LOTS (2430456103 , 2430562103) AND A RANDOM LOT, RUN IN DUPLICATE ON V08.01 SOFTWARE. TESTING ON VITEK® MS WITH V3.2 KNOWLEDGE BASE WAS ALSO PERFORMED. ISOLATE 911615 (715526330): FOR 5 OF THE 6 CARDS TESTED, A GOOD ID (90%) OF C. HAEMULONII WAS OBTAINED. ON THE REMAINING CARD, A LOW DISCRIMINATION CALL OF C. HAEMULONII/C. DUOBUSHAEMULONII WAS OBTAINED. VITEK MS GAVE AN IDENTIFICATION OF C. AURIS, WITH A 99.9% CONFIDENCE VALUE. ISOLATE 911616 (713793230): ON ALL SIX (6) CARDS, A VERY GOOD OR ACCEPTABLE ID OF C. HAEMULONII WAS OBTAINED. VITEK MS GAVE AN IDENTIFICATION OF C. AURIS, WITH A 99.9% CONFIDENCE VALUE. A COMPARISON OF CARD REACTION RESULTS FOR C. HAEMULONII AGAINST EXPECTED REACTION RESULTS FOR C. AURIS SHOWED THREE (3) ATYPICAL POSITIVE REACTIONS (GLYLA, IRHAA, XLTA) AND TWO (2) ATYPICAL NEGATIVE REACTIONS (TYRA, DMLZA) THAT LED TO THE INCORRECT CALL. A COMPARISON OF CUSTOMER CARD REACTION RESULTS FOR THE LOW DISCRIMINATION RESULTS AGAINST EXPECTED REACTION RESULTS FOR C. AURIS SHOWED THREE (3) ATYPICAL POSITIVE REACTIONS (GLYLA, IRHAA, XLTA) AND TWO (2) ATYPICAL NEGATIVE REACTIONS (DGALA, DMLZA) THAT LED TO THE INCORRECT CALL. AN INCREASED NUMBER OF ATYPICAL REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON-RECOMMENDED MEDIA, USER SET UP ERROR, OR AN ATYPICAL STRAIN. THE INVESTIGATION CONCLUDED THAT THE STRAINS EXHIBITED ATYPICAL GROWTH BEHAVIOR, AND THE VITEK 2 YST TEST KIT PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CANDIDA AURIS AS CANDIDA HAEMULONII IN ASSOCIATION WITH THE VITEK® 2 YST ID TEST KIT. THE CUSTOMER SENT THE ORGANISM STRAINS TO A REFERENCE LABORATORY FOR CONFIRMATORY TESTING VIA VITEK 2; THE REFERENCE LABORATORY CONFIRMED THE IDENTIFICATION TO CANDIDA HAEMULONII. THE CUSTOMER ALSO SENT THE ORGANISM STRAINS TO A REFERENCE LABORATORY FOR CONFIRMATORY TESTING VIA BRUKER MALDI TOF; THE RESULTS WERE RETURNED AS CANDIDA AURIS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. 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
    231393 VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT VITEK® 2 YST ID CARD JXB BIOMÉRIEUX, INC. 2430456103 03573026131937

    Patients

    Seq Age Sex Outcome Treatment
    1