BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LYFOCULTS® PLUS CANDIDA KRUSEI

    MDR report key: 5285950 · Received December 10, 2015

    Report

    Report Number
    3002769706-2015-00164
    Event Type
    Malfunction
    Date Received
    December 10, 2015
    Report Date
    November 15, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JTR
    PMA / PMN Number
    CL I, EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. THE CUSTOMER'S QC STRAIN AND THE IN-HOUSE QC STRAIN WERE SUB-CULTURED AND AMPHOTERICIN B TESTING INCLUDED TWO (2) AST-YS07 CARDS FROM THE SAME LOT AS THAT TESTED BY THE CUSTOMER AND TWO (2) CARDS FROM A RANDOM LOT. ALL AST-YS07 CARDS TESTED FOR EACH QC STRAIN PROVIDED ACCEPTABLE MICS = 0.5 OR 1. THE VITEK AST-YS07 CARDS ARE PERFORMING IN ACCORDANCE WITH SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER CONTACTED BIOMERIEUX TO REPORT A DISCREPANT RESULTS WHEN USING PRODUCT LYFOCULTS PLUS CANDIDA KRUSEI DURING AN INTERNAL QUALITY CONTROL TEST. THE CUSTOMER STATED THE MIC, MINIMUM INHIBITORY CONCENTRATION RANGE, OF THE AMPHOTERICINA B WAS:<0,25 AND THE EXPECTED RANGE WAS 0,50< 2.00. THE CUSTOMER STATED THAT RETESTING WAS PERFORMED ON THE SUBJECT STRAIN USING TWO DIFFERENT VITEK 2 SYSTEMS; ANOMALIES WERE NOTED ON BOTH SYSTEMS QC RESULTS. THERE ARE NO ISSUES WITH OTHER STRAINS OF CANDIDA SPECIES OR TESTING PROCESS; OPERATED CORRECTLY ALL STAGES OF SAMPLE PREPARATION INCLUDING CONTROLS ON STERILITY. NO PATIENT RESULTS WERE AFFECTED OR DELAYED RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815959 LYFOCULTS® PLUS CANDIDA KRUSEI LYFOCULTS® PLUS CANDIDA KRUSEI JTR BIOMERIEUX SA 1003575250

    Patients

    Seq Age Sex Outcome Treatment
    1