BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLISENS® EASY MAG® DISPOSABLE VESSEL

    MDR report key: 6969078 · Received October 23, 2017

    Report

    Report Number
    3002769706-2017-00308
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Report Date
    February 14, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JJH
    UDI-DI
    03573026139360
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A PERFORMANCE ISSUE ASSOCIATED WITH NUCLISENS® EASY MAG® DISPOSABLE VESSEL(REFERENCE 280135). THE CUSTOMER'S ISSUE COULD NOT BE REPRODUCED DUE TO THE FACT THAT THE CUSTOMER HAD ALREADY DISCARDED HIS DEFECTIVE ASPIRATORS, AND THERE WERE NO REMAINING NUCLISENS EASYMAG DISPOSABLE (REF 280135_LOT Z108HB) AVAILABLE IN STOCK. AS NO DEFECTIVE SAMPLES COULD BE SENT TO THE SUPPLIER, THE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, THE TWO PROBABLE ROOT CAUSES IDENTIFIED ARE: AN INSPECTION ISSUE DURING THE 100% VISUAL CONTROL OF ASSEMBLED PIECES, OR AN ASSEMBLY ERROR THAT LED TO A TIP DETACHMENT AFTER INSPECTION. THE SYSTEM INFORMED THE USER AS EXPECTED WITH A WARNING/ERROR MESSAGE. THEREFORE, THE ISSUE WAS DETECTED AND MANAGED CORRECTLY.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A PERFORMANCE ISSUE ASSOCIATED WITH NUCLISENS® EASY MAG® DISPOSABLE VESSEL ((B)(4)). THE CUSTOMER REPORTED THAT THE TIP WAS MISSING FROM THE CARTRIDGE AFTER RUN COMPLETION ON TWO (2) DIFFERENT EASYMAGS (EM 5 AND EM 9). ON BOTH OCCURRENCES, THE ISSUE WAS ON CARTRIDGE POSITION A THE SECOND TIP POSITION. AFTER THE RUNS COMPLETED, THE SECOND TIP FROM THE LEFT ON BOTH AFFECTED TIP CARTRIDGES WERE MISSING. THE CUSTOMER REPORTED THIS LEAD TO A DELAY IN REPORTING RESULTS LESS THAN 24 HOURS, AND THERE NO INDICATION OR REPORT 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
    748324 NUCLISENS® EASY MAG® DISPOSABLE VESSEL NUCLISENS® EASY MAG® DISPOSABLE VESSEL JJH BIOMERIEUX SA Z108HB 03573026139360

    Patients

    Seq Age Sex Outcome Treatment
    1