BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIMA ASSURANCE+LAUNCHPAD PC

    MDR report key: 6144476 · Received December 5, 2016

    Report

    Report Number
    3002769706-2016-00496
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Report Date
    May 23, 2017
    Manufacturer
    BIOMERIEUX, S.A.
    Product Code
    PEX
    PMA / PMN Number
    K124067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS FOR ONE STRAIN WITH THE VITEK® MS INSTRUMENT (B)(4). THE CUSTOMER SUBMITTED THE STRAIN FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE CUSTOMER'S STRAIN WAS TESTED AND AN IDENTIFICATION TO STAPHYLOCOCCUS AUREUS WAS CONFIRMED ON VITEK® MS V2, ON API STAPH AND ID 32 STAPH. ANALYSIS WAS PERFORMED ON THE CUSTOMER'S MZML FILES AND THE BIOMÉRIEUX QUALITY CONTROL'S MZML FILES, WHICH WERE COMPARED WITH REFERENCE SPECTRA OF S. AUREUS AND S. LUGDUNENSIS. BASED ON ANALYSIS, THE MOST PROBABLE IDENTIFICATION OF THE CUSTOMER STRAIN IS STAPHYLOCOCCUS AUREUS AND NOT STAPHYLOCOCCUS LUGDUNENSIS. THE CUSTOMER MENTIONED THAT THE STRAIN WAS PYR POSITIVE, HOWEVER, THIS WAS NOT CONFIRMED INTERNALLY ON ID32STAPH. THE ANALYSIS OF OTHER SPECIFIC TESTS OF THE ID32 STAPH STRIP WERE IN FAVOR OF S. AUREUS. THE INVESTIGATION CONCLUDED THE VITEK® MS SYSTEM PROVIDED THE CORRECT IDENTIFICATION RESULT AND PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS FOR ONE STRAIN WITH THE VITEK® MS INSTRUMENT. THE FIRST RESULT GAVE STAPHYLOCOCCUS AUREUS (SCORE 99.9%) AND THE SECOND STAPHYLOCOCCUS LUGDUNENSIS. THE METHOD USED TO CHECK THE RESULT WAS PERFORMED WITH VITEK® 2 AND CONFIRMED BY PYR TESTING (PYR POS). THE DISCREPANT RESULT WAS REPORTED TO THE PHYSICIAN. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795382 AXIMA ASSURANCE+LAUNCHPAD PC AXIMA ASSURANCE+LAUNCHPAD PC PEX BIOMERIEUX, S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1