BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5400 CHEMISTRY ANALYZER

    MDR report key: 2091884 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01819
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K011720
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTS DETECTING CUVETTE OVERFLOW BY REVIEWING REACTION MONITOR AND RUNNING PHOTOCAL ON CUVETTES. PHOTOCAL FAILED. THE CUSTOMER FOUND WATER IN THE CUVETTES AND DRIER NOZZLES WORN. A BCI FIELD SERVICE ENGINEER (FSE) REPAIRED AND REPLACED THE TORN DIAPHRAGMS IN THE VACUUM PUMP AND REMOVED DEBRIS FROM THE ASPIRATION NOZZLES. POST SERVICE SYSTEM IS OPERATIONAL. ROOT CAUSE IS CUVETTE OVERFLOW CAUSED BY INSUFFICIENT VACUUM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN ERRONEOUS HIGH CREATININE RESULTS ON EIGHT (8) SAMPLES GENERATED BY THE AU5400 CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE UNIT AND LOWER RESULTS WITHIN REFERENCE RANGE WERE OBTAINED AND REPORTED WITHIN THREE HOURS. THE CUSTOMER NOT AWARE OF ANY PATIENT RECEIVING TREATMENT DUE TO ORIGINAL REPORTED CREATININE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU5400 CHEMISTRY ANALYZER AU5400 CHEMISTRY ANALYZER, AU5431-02 W/OSV JJE BECKMAN COULTER MISHIMA K.K. AU5431-02 W/OSV N/A

    Patients

    Seq Age Sex Outcome Treatment
    1