BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7590866 · Received June 12, 2018

    Report

    Report Number
    1950204-2018-00221
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Report Date
    July 23, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF A CANDIDA GUILLIERMONDII CAP SURVEY STRAIN (F1-02 2018) AS CANDIDA FAMATAN IN ASSOCIATION WITH THE VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT. AN INVESTIGATION WAS PERFORMED. THE EXPECTED IDENTIFICATION IS CANDIDA GUILLIERMONDII, BUT THE CUSTOMER OBTAINED AN EXCELLENT IDENTIFICATION OF C. FAMATA ON YST LOT 2430167403. WHEN TESTED AGAIN ON A SECOND LOT (2430364203), A LOW DISCRIMINATION RESULT OF C. FAMATA/C. GUILLIERMONDII WAS OBTAINED. THE CUSTOMER REPORTED C. FAMATA TO CAP. IT SHOULD BE NOTED THAT BOTH C. GUILLIERMONDII AND C. FAMATA/C. GUILLIERMONDII WERE ACCEPTABLE ANSWERS; HOWEVER, C. FAMATA ALONE WAS NOT. BOTH THE CUSTOMER SUBMITTED STRAIN AND THE INTERNAL CAP SURVEY STRAIN WERE SUBBED AND TESTED ON THE CUSTOMER LOT 2430364203 (2430167403 HAS SINCE EXPIRED) AND A RANDOM LOT OF YST CARDS, IN DUPLICATE. API 20C AUX AND VITEK MS WERE ALSO PERFORMED. 911606 (CUSTOMER SUBMITTED STRAIN): ON ALL FOUR CARDS TESTED, AN EXCELLENT IDENTIFICATION OF C. FAMATA WAS OBTAINED. API 20C AUX GAVE A VERY GOOD ID (99.7%) OF C. GUILLIERMONDII AND VITEK MS GAVE AN IDENTIFICATION OF C. GUILLIERMONDII, WITH A 99.9% CONFIDENCE LEVEL. 911599 (INTERNAL SURVEY STRAIN): ON ONE OF THE CUSTOMER LOT CARDS AND ONE OF THE RANDOM LOT CARDS, A LOW DISCRIMINATION CALL OF C. FAMATA/C. GUILLIERMONDII WAS OBTAINED. ON ONE OF THE CUSTOMER LOT CARDS AND ONE OF THE RANDOM LOT CARDS, AN EXCELLENT ID OF C. FAMATA WAS OBTAINED. API 20C AUX GAVE A VERY GOOD ID (99.7%) OF C. GUILLIERMONDII AND VITEK MS GAVE AN IDENTIFICATION OF C. GUILLIERMONDII, WITH A 99.9% CONFIDENCE LEVEL. A COMPARISON OF CARD REACTION RESULTS FOR C. FAMATA AGAINST EXPECTED REACTION RESULTS FOR C. GUILLIERMONDII REVEALED ONE ATYPICAL NEGATIVE REACTION (DGATA) THAT LED TO THE INCORRECT CALL. THE INVESTIGATION CONCLUDED THAT THIS IS AN ATYPICAL STRAIN. THE VITEK 2 YST CARD PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF CAP SURVEY STRAIN CANDIDA GUILLIERMONDI IN ASSOCIATION WITH THE VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT. THE VITEK 2 YST ID CARD IDENTIFIED THE STRAIN TO CANDIDA FAMATA. REPEAT TEST OBTAINED THE SAME RESULT. THE CUSTOMER SUBMITTED THE IDENTIFICATION OF CANDIDA FAMATA TO CAP. CAP INDICATED THE RESULT TO BE INCORRECT; CANDIDA GUILLIERMONDI WAS THE EXPECTED RESULT. THE CUSTOMER STATED THEY PLATE THE DIRECT SPECIMEN, SUB-CULTURE IT ONCE, THEN TEST ON THE VITEK 2 SYSTEM ACCORDING TO CAP INSTRUCTIONS. FOLLOWING RECEIPT OF THE CAP ANSWER, THE CUSTOMER PERFORMED TESTING ON THE CAP STRAIN VIA VITEK MS, AND OBTAINED THE EXPECTED RESULT OF CANDIDA GUILLIERMONDI. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PERSON'S STATE OF HEALTH, AS THERE IS NO PATIENT ASSOCIATED WITH THE CAP SURVEY STRAIN, BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432771 VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT VITEK® 2 YST ID CARD JXB BIOMÉRIEUX, INC. 2430167403 03573026131937

    Patients

    Seq Age Sex Outcome Treatment
    1