BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER (AU5431-02)

    MDR report key: 2252221 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05083
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BECKMAN COULTER MISHIMAK.K.
    Product Code
    JJE
    PMA / PMN Number
    K011720
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL QC FOR ALL TESTS AND CALIBRATIONS ON THE INSTRUMENT RESULTED WITHIN RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 FOR THIS EVENT. THE CUSTOMER NOTICED BUILDUP OF DETERGENT AROUND THE CUVETTES ON REACTION CAROUSEL. THE FSE CHECKED THE WASH DISPENSE AND VACUUM. THE FSE CLEANED FOUR VACUUM NOZZLES. NO ISSUES HAVE BEEN REPORTED WITH THIS INSTRUMENT SINCE. ROOT CAUSE IS UNKNOWN FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING AN ERRONEOUSLY HIGH CREATININE (CRE) RESULT GENERATED BY THE OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER (B)(4). THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE ORIGINAL CRE RESULT FROM THE POUR-OFF (ANALYZED IN A SECONDARY TUBE) YEILDED 3.70 MG/DL. UPON REPEAT FROM THE POUR-OFF YIELDED A RESULT OF 0.55 MG/DL. UPON A SECOND REPEAT, COLLECTED FROM THE ORIGINAL SST SAMPLE, YEILDED A CRE RESULT OF 0.59 MG/DL. NO INJURY OR AFFECT TO PATIENT TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER (AU5431-02) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER MISHIMAK.K. AU5431-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1