BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2395838 · Received January 3, 2012

    Report

    Report Number
    2050012-2012-00007
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 12, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JGS
    PMA / PMN Number
    K011720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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) IDENTIFIED THAT THE SAMPLE PROBE TIP WAS WORN. THE FSE REPLACED THE SAMPLE PROBE. A SUBSEQUENT INSTRUMENT CHEMISTRY PERFORMANCE ASSESSMENT YIELDED ACCEPTABLE RESULTS. UPON COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS LOW SODIUM, POTASSIUM AND CHLORIDE RESULTS WERE GENERATED FROM AN OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER FOR ONE PATIENT. ALL OF THE ERRONEOUS RESULTS WERE CAUSED BY THE SAME INSTRUMENT ISSUE. THE CUSTOMER WAS EXPERIENCING OUT OF RANGE QUALITY CONTROL RESULTS DURING THE TIMEFRAME OF THE EVENT AND ELECTED TO REPEAT PREVIOUSLY GENERATED PATIENT RESULTS ALL REPEAT PATIENT RESULTS REPEATED COMPARABLY EXCLUDING THE PATIENT RESULTS INVOLVED IN THIS EVENT. UPON REPEAT, THIS PATIENT'S SODIUM, POTASSIUM AND CHLORIDE REPEAT RESULTS WERE HIGHER AND CONSIDERED VALID. THE INITIAL, ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. NO PATIENT SPECIFIC INFORMATION, SAMPLE HANDLING/COLLECTION INFORMATION OR ADDITIONAL 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