BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2233734 · Received September 3, 2011

    Report

    Report Number
    2050012-2011-04753
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JGS
    PMA / PMN Number
    K011720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND A CLOT IN THE INLET BLOCK OF FLOW CELL. THE FSE CLEARED THE CLOT. THE FSE PERFORMED AN ION-SELECTIVE ELECTRODE CHEMISTRY CALIBRATION, QUALITY CONTROL (QC) AND PRECISION ASSESSMENT ON ALL 3 LEVELS OF QC WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS RETURNED TO SERVICE AFTER THE NECESSARY REPAIRS. THE ROOT CAUSE OF THIS EVENT WAS A CLOGGED INLET BLOCK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AN ERRONEOUS LOW SODIUM RESULT WAS GENERATED FROM AN OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY BUT WAS QUESTIONED BY THE PHYSICIAN. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. UPON TEST REPEAT, THE SODIUM REPEAT RESULT WAS HIGHER. NO PATIENT SPECIFIC INFORMATION, SAMPLE HANDLING/COLLECTION INFORMATION OR SYSTEM INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY JGS BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1