BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-N288 TEST KIT

    MDR report key: 6481611 · Received April 11, 2017

    Report

    Report Number
    1950204-2017-00115
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Report Date
    February 16, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTT
    PMA / PMN Number
    K860031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) HAD NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 AST-N288 TEST KIT. THE CUSTOMER REPORTED RESULTS PER VITEK® 2 AST-N288 FOR PROTEUS MIRABILIS WERE INTERMEDIATE (I) FOR IMIPENEM; HOWEVER, THE RESULTS USING ANOTHER METHOD WERE SUSCEPTIBLE (S). THIS IS A DUPLICATE CUSTOMER COMPLAINT. THIS ISSUE HAS ALREADY BEEN REPORTED WITH MEDWATCH 1950204-2017-00016. THE RESULTS OF THE SUBSEQUENT INVESTIGATION WERE REPORTED WITH MEDWATCH 1950204-2017-00016 SUPPLEMENT 1.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 AST-N288 TEST KIT. THE CUSTOMER REPORTED THE RESULTS PER VITEK® 2 AST-N288 FOR PROTEUS MIRABILIS WERE INTERMEDIATE (I) FOR IMIPENEM; HOWEVER, THE RESULTS USING ANOTHER METHOD WERE SUSCEPTIBLE (S). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266049 VITEK® 2 AST-N288 TEST KIT VITEK® 2 AST-N288 TEST KIT JTT BIOMERIEUX, INC 7080178403

    Patients

    Seq Age Sex Outcome Treatment
    1