BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 YST TEST KIT

    MDR report key: 7558261 · Received May 31, 2018

    Report

    Report Number
    1950204-2018-00201
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Report Date
    July 10, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    JXB
    UDI-DI
    03573026131937
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. A UNITED STATES CUSTOMER OBTAINED AN INCORRECT IDENTIFICATION WHEN TESTING CAP SURVEY ISOLATE F1-02 2018 ON VITEK 2 YST CARDS. THE EXPECTED IDENTIFICATION IS CANDIDA GUILLIERMONDII; HOWEVER, THE CUSTOMER OBTAINED AN EXCELLENT IDENTIFICATION OF CANDIDA FAMATA. ON A SECOND RUN, THE CUSTOMER OBTAINED A LOW DISCRIMINATION CALL OF C. FAMATA/C. GUILLIERMONDII. THEREFORE, THE CUSTOMER REPORTED C. FAMATA AS THEIR FINAL ANSWER. 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 AND A RANDOM LOT OF VITEK 2 YST CARDS, IN DUPLICATE. API® 20C AUX AND VITEK® MS WERE ALSO PERFORMED. CUSTOMER SUBMITTED STRAIN (911598): ON ALL FOUR (4) CARDS TESTED, A LOW DISCRIMINATION CALL OF C. FAMATA/C. GUILLIERMONDII 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. SINCE C. GUILLIERMONDII WAS PART OF THE LOW DISCRIMINATION CALL ON ALL CARDS TESTED, CARDS ARE PERFORMING AS EXPECTED FOR THIS ORGANISM. INTERNAL SURVEY STRAIN (911599): A LOW DISCRIMINATION CALL OF C. FAMATA/C. GUILLIERMONDII WAS OBTAINED ON ONE (1) CARD FROM THE CUSTOMER LOT AND ONE (1) CARD FROM THE RANDOM LOT. AN EXCELLENT ID OF C. FAMATA WAS OBTAINED ON ONE (1) CARD FROM THE CUSTOMER LOT AND ONE (1) CARD FROM THE RANDOM LOT. 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 AGAINST EXPECTED REACTION RESULTS FOR C. GUILLIERMONDII REVEALED ONE (1) ATYPICAL NEGATIVE REACTION (DGATA) THAT LED TO THE INCORRECT CALL. CONCLUSION: ATYPICAL STRAIN A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE DURING THE LAST 13 MONTH TIMEFRAME WITH NO IMPLICATION OF A TREND. THE MOST RECENT QUARTERLY TREND REVIEW DID NOT IDENTIFY THIS COMPLAINT AS A SYSTEMIC QUALITY ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A MISIDENTIFICATION OF A CANDIDA GUILLIERMONDII CAP SURVEY SAMPLE (F1-02), AS CANDIDA FAMATA IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT. THE CUSTOMER REPORTED CANDIDA FAMATA AS THEIR IDENTIFICATION. REPEAT TESTING GAVE A RESULT OF LOW DISCRIMINATION BETWEEN C. GUILLERMONDII AND C. FAMATA. THE CUSTOMER SUBMITTED THE LAB AND THE CAP SURVEY REPORTS FOR EVALUATION. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400549 VITEK® 2 YST TEST KIT VITEK® 2 YST TEST KIT JXB BIOMERIEUX INC. 2430590203 03573026131937

    Patients

    Seq Age Sex Outcome Treatment
    1