BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 YST TEST KIT

    MDR report key: 7466564 · Received April 26, 2018

    Report

    Report Number
    1950204-2018-00163
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Report Date
    August 28, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    JXB
    UDI-DI
    03573026131937
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED DUE TO A MISIDENTIFICATION OF TWO (2) STRAINS OF CANDIDA AURIS WITH VITEK® 2 V8.01 YST CARD. TWO STRAINS (#104245 CALLED S1 AND CBS #10913 CALLED S2) WERE RECEIVED AT BIOMÉRIEUX. THE IDENTIFICATION TO CANDIDA AURIS WAS CONFIRMED ON VITEK® MS V3 (KNOWLEDGE BASE V3.2) FOR THE TWO (2) SUBMITTED STRAINS. ON VITEK 2 (V8.01) YST CARD, TWO (2) CARDS OF CUSTOMER LOTS (CL1: 2430316403 AND CL2: 2430518203) AND ONE (1) CARD OF RANDOM LOT (RL: 2430385203) WERE TESTED FROM CHROMID® CANDIDA (CAN2 BIOMERIEUX) SUBCULTURE FOR EACH STRAIN. THESE TESTS GAVE: STRAIN 1 = VERY GOOD OR GOOD IDENTIFICATION TO CANDIDA DUOBUSHAEMULONII ON THE THREE (3) LOTS TESTED. STRAIN 2 = EXCELLENT IDENTIFICATION TO CANDIDA DUOBUSHAEMULONII ON THE THREE (3) LOTS TESTED. THE MISIDENTIFICATION OBTAINED BY THE CUSTOMER WAS DUPLICATED. A REVIEW OF THE CUSTOMER'S CANDIDA DUOBUSHAEMULONII REACTIONS DEMONSTRATED TWO (2) ATYPICAL NEGATIVE REACTIONS (TYRA , NAGA) FOR AN IDENTIFICATION OF CANDIDA AURIS ACCORDING TO YST KNOWLEDGE BASE. 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 (B)(6) REPORTED A MISIDENTIFICATION OF A CANDIDA AURIS STRAIN FROM A PATIENT'S EAR SWAB, AS CANDIDA DUOBUSHEMULONII, IN ASSOCIATION WITH THE VITEK® 2 YST TEST KIT (LOT 2430316403). THE CUSTOMER REPORTED THAT THE PATIENT ISOLATE WAS INITIALLY IDENTIFIED CORRECTLY AS C. AURIS (90%) WITH THE YST CARD. HOWEVER, REPEAT TESTING WITH THE YST CARD IDENTIFIED CANDIDA DUOBUSHEMULONII. THE BRUKER ID OBTAINED IDENTIFICATION OF C. AURIS BUT WITH A BAD SCORE IN RESEARCH USE ONLY MODE. THE CONTROL STRAIN ((B)(4)) ALSO MISIDENTIFIED AS C. DUOBUSHEMULONII. THE CUSTOMER STATED THAT THE STRAINS WERE TESTED ON TWO DIFFERENT INSTRUMENTS, WITH TWO DIFFERENT LOTS. THE MEDIA USED FOR THE FIRST TESTING WAS PVX (CHOCOLATE AGAR + POLYVITEX) AND WAS USED AFTER 24H CO2 35°C. THE RETESTING WAS DONE FROM CHROMID® CANDIDA AFTER 48H 35°C AND 72H 35°C. THE CUSTOMER REPORTED THAT PATIENT RESULTS AND TREATMENT WERE NOT IMPACTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307921 VITEK® 2 YST TEST KIT VITEK® 2 YST TEST KIT JXB BIOMERIEUX INC. 2430316403 03573026131937

    Patients

    Seq Age Sex Outcome Treatment
    1