BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 YST TEST KIT

    MDR report key: 7129843 · Received December 19, 2017

    Report

    Report Number
    1950204-2017-00462
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Report Date
    June 8, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JXB
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A CANDIDA ALBICANS QUALITY CONTROL STRAIN (ATCC 14053), AS STEPHANOASCUS CIFERRII IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT (LOT 2430441103). AN INVESTIGATION WAS PERFORMED. THE CUSTOMER'S TESTS PERFORMED FROM BD¿ CHROMAGAR¿GAVE MULTIPLE DISCREPANT RESULTS, AND FALSE POSITIVE REACTIONS (EXAMPLE : ERYA, ARBA, GENA, DRAFA). THE CUSTOMER DID NOT REPRODUCE THESE RESULTS FROM SABOURAUD MEDIUM (REQUIRED FOR QUALITY CONTROL TESTING). ON VITEK2 (V7.01), TESTS WERE PERFORMED FROM SDA SUBCULTURE UNDER AEROBIC ATMOSPHERE AS RECOMMENDED. TWO LOTS OF YST CARD, CUSTOMER LOT 2430441103 (CL) AND RANDOM LOT 2430385203 (RL), WERE TESTED TWICE WITH THE INTERNAL REFERENCE STRAIN (CUSTOMER STRAIN NOT AVAILABLE). ALL BIOCHEMICAL TESTS CONFORMED WITH BOTH LOTS TESTED. THE IDENTIFICATION OBTAINED WAS C. ALBICANS AS INTENDED. IN CONCLUSION, THE CUSTOMER MISIDENTIFICATIONS WERE NOT REPRODUCED IN-HOUSE. THE QC TESTING CONFORMED AND THE VITEK 2 YST CARD PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A CANDIDA ALBICANS QUALITY CONTROL STRAIN (ATCC 14053), AS STEPHANOASCUS CIFERRII IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT (LOT 2430441103). THE CUSTOMER REPORTED THAT THE QC FAILED TWICE IN SEVERAL REACTIONS (ERYA, GENA, DRAFA, IRHAA, URE). LATER THE CUSTOMER REPORTED THAT THE QC WAS DONE FROM SAB AGAR (OXOID/BD) MEDIA AND FAILED. THEN THE CUSTOMER PERFORMED QC AGAIN FROM SAB AGAR (BIOMÉRIEUX) AND REPORTED THE QC PASSED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907895 VITEK® 2 YST TEST KIT VITEK® 2 YST TEST KIT JXB BIOMERIEUX, INC 2430441103

    Patients

    Seq Age Sex Outcome Treatment
    1