BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P586 TEST KIT

    MDR report key: 5206097 · Received November 5, 2015

    Report

    Report Number
    1950204-2015-00092
    Event Type
    Malfunction
    Date Received
    November 5, 2015
    Report Date
    November 4, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K113783
    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

    THE CUSTOMER DID NOT COMPLY WITH BIOMÉRIEUX'S REQUEST FOR SUBMITTAL OF THE ATCC® 29212 TM QC STRAIN, LAB REPORTS OR RAW DATA. BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED USING BIOMÉRIEUX'S INTERNAL ATCC® 29212 QC STRAIN, TWO CARDS FROM THE CUSTOMER AST-P586 LOT AND TWO CARDS EACH FROM TWO RANDOM LOTS. ALL AST-P586 CARDS TESTED OBTAINED ACCEPTABLE QC RESULTS FOR BENZYLPENICILLIN (MIC=2, RANGE IS 1 - 4) AND QUINUDALFOPRISTIN (MIC=8, RANGE IS 1 - 8). EVALUATION OF THE MANUFACTURING QC RECORDS FOR THE LOT IN QUESTION INDICATED THE LOT PASSED QC TESTING AND THERE WERE NO ISSUES WITH BENZYLPENICILLIN AND QUINUDALFOPRISTIN ON INITIAL PERFORMANCE TESTING. THE AST-P586 TEST KITS ARE PERFORMING IN ACCORDANCE WITH SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN ITALY REPORTED FALSE SUSCEPTIBLE BENZYLPENICILLIN AND QUINUDALFOPRISTIN RESULTS FOR ENTEROCOCCUS FAECALIS ATCC 29212 WHEN TESTED WITH THE VITEK 2 AST-P586 TEST KIT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THE (B)(6) RESULT IS NOT DIRECTLY ASSOCIATED WITH ANY PATIENT. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733851 VITEK 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P586 TEST KIT VITEK 2 AST-P586 CARD LON BIOMERIEUX, INC 366359910

    Patients

    Seq Age Sex Outcome Treatment
    1