BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6308527 · Received February 7, 2017

    Report

    Report Number
    1950204-2017-00046
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 10, 2017
    Report Date
    April 19, 2017
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    JXB
    PMA / PMN Number
    K881925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT UNIDENTIFIED RESULTS IN ASSOCIATION WITH THE VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER REPORTED SETTING UP ISOLATES FROM SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL AND GENTAMICIN (SAB C&G). SAB C&G IS NOT A RECOMMENDED MEDIA IN THE YST CULTURE REQUIREMENTS TABLE. THE CUSTOMER REPORTED THAT THE IDENTIFICATION ISSUES WITH THE YST CARD RESOLVED WHEN TESTING WAS PERFORMED WITH A RECOMMENDED MEDIA, SABOURAUD DEXTROSE AGAR. TWELVE LAB REPORTS WERE SUBMITTED FROM TESTING WITH SAB C&G. TWO (2) LAB REPORTS SHOWED UNIDENTIFIED RESULTS WHILE THE API RESULT WAS CANDIDA LUSITANIAE. ONE (1) LAB REPORT SHOWED AN UNIDENTIFIED RESULT WHILE MALDI-TOF RESULT WAS CANDIDA KEFYR. THREE (3) LAB REPORTS SHOWED UNIDENTIFIED RESULTS WHILE MALDI-TOF RESULT WAS SACCHAROMYCES CEREVISIAE. ONE (1) LAB REPORT SHOWED A LOW DISCRIMINATION RESULT FOR R. GLUTINIS/MUCILAGINOSA (C. LAURENTII) WHILE MALDI-TOF RESULT WAS TRICHOSPORON MUCOIDES. TWO (2) LAB REPORTS SHOWED UNIDENTIFIED RESULTS WHILE MALDI-TOF RESULT WAS CANDIDA PARAPSILOSIS. ONE (1) LAB REPORT SHOWED A LOW DISCRIMINATION RESULT FOR CANDIDA FAMATA/CANDIDA PARAPSILOSIS WHILE MALDI-TOF RESULT WAS CANDIDA PARAPSILOSIS. ONE (1) LAB REPORT SHOWED A LOW DISCRIMINATION RESULT FOR R. GLUTINIS/MUCILAGINOSA (C. LAURENTII), CANDIDA ALBICANS, CANDIDA RUGOSA WHILE MALDI-TOF RESULT WAS CANDIDA RUGOSA. ONE (1) LAB REPORT SHOWED A LOW DISCRIMINATION RESULT FOR R. GLUTINIS/MUCILAGINOSA (C. LAURENTII), CANDIDA GLABRATA WHILE MALDI-TOF RESULT WAS CANDIDA GLABRATA. AN INCREASED NUMBER OF ATYPICAL REACTIONS CAN RESULT WHEN USING NON-RECOMMENDED MEDIA, WHICH MAY LEAD TO UNIDENTIFIED, LOW DISCRIMINATION OR MIS-IDENTIFICATION RESULTS SINCE THESE REACTIONS ARE NOT INCLUDED IN THE YST KNOWLEDGE BASE. NO ISOLATE WAS SUBMITTED SO ISSUE COULD NOT BE FURTHER INVESTIGATED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT UNIDENTIFIED RESULTS IN ASSOCIATION WITH THE VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT. THE CUSTOMER REPEATED THE TESTING AND RECEIVED THE EXPECTED RESULT WITH MALDI OR API. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH; HOWEVER THERE WAS A DELAY GREATER THAN 24 HOURS IN REPORTING THE RESULT TO THE PHYSICIAN. THERE MAY BE A POTENTIAL FOR ADVERSE EVENT IF THE EVENT WERE TO REOCCUR WHILE TESTING A PATIENT ISOLATE; THEREFORE THIS EVENT IS BEING REPORTED AS A MALFUNCTION. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89196 VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT JXB BIOMERIEUX INC. 2430063103

    Patients

    Seq Age Sex Outcome Treatment
    1