BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2111664 · Received June 2, 2011

    Report

    Report Number
    2050012-2011-02062
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER DETAILS WERE RECEIVED AFTER THE INITIAL SUBMISSION AND ADDED.

    Additional Manufacturer Narrative · 1

    VERIFICATIONS WERE PERFORMED ON-SITE TO CONFIRM REAGENT AND SAMPLE PROBE ALIGNMENT. NO LEAKS WERE OBSERVED AND THE ASSAY PARAMETERS WERE VERIFIED AS CORRECTLY CONFIGURED. REAGENT CAROUSELS WERE ASSESSED AND FOUND TO BE IN GOOD WORKING ORDER. A DEFINITIVE ROOT CAUSE HAS NOT BEEN IDENTIFIED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AND ERRONEOUS HIGH UREA RESULT WAS GENERATED ON THE OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER FOR ONE PATIENT SAMPLE. THE RESULT WAS RELEASED FROM THE LABORATORY. THE ACTUAL REPORTED RESULT VALUE IS UNKNOWN. IT IS UNKNOWN AS TO WHETHER THERE WAS A DEATH, SERIOUS INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE CUSTOMER INDICATED UREA QUALITY CONTROL RESULTS AND PATIENT SAMPLE RECOVERY DECREASES WHEN THE VOLUME OF THE REAGENT LOWERS BELOW A SPECIFIC LEVEL. ACCORDING TO THE CUSTOMER THIS HAS BEEN A REPEATING ISSUE OVER A ONE YEAR TIMEFRAME. THIS WAS THE FIRST REPORT OF THIS ISSUE BECAUSE IT WAS TIED TO THE RELEASE OF AN ERRONEOUS RESULT. THE INITIAL REPORTER CONTACT INFORMATION IS NOT KNOWN AT THE CURRENT TIME. THE ISSUE WAS REPORTED INTO BECKMAN COULTER INC. BY A COMPANY REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UREA BUN