BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2114077 · Received June 6, 2011

    Report

    Report Number
    2050012-2011-02061
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE R1 REAGENT PROBE WAS REPLACED ON THE INSTRUMENT, AND THE INSTRUMENT WAS RETURNED INTO SERVICE. THE CUSTOMER IS NO LONGER REPORTING PROBLEMS WITH RECOVERY. ALTHOUGH A REPAIR WAS PERFORMED A DEFINITIVE ROOT CAUSE HAS NOT BEEN IDENTIFIED TO DATE. THE MDRS ASSOCIATED WITH THIS EVENT CONSIST OF: 2050012-2011-02061, 2050012-2011-02060.

    Additional Manufacturer Narrative · 1

    AN INCORRECT PRODUCT CLASSIFICATION CODE WAS INITIALLY REPORTED AS "CKB". THE CORRECT PRODUCT CLASSIFICATION FOR THIS INSTRUMENT IS "JJE"

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE EXPERIENCING NON-REPRODUCIBLE CALCIUM RESULTS GENERATED FROM A OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER WAS REPEATING ALL OF THEIR HIGH CALCIUM RESULTS AND SOME REPEAT RESULTS SHOW LOWER RECOVERIES. DATA WAS PROVIDED THAT INDICATED THE NON-REPRODUCIBILITY OF TWO CALCIUM VALUES GENERATED ON AN OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER. THIS REPORT REPRESENTS SAMPLE NUMBER ONE. THE INITIAL RESULT WAS REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN AS TO WHETHER THERE WAS A DEATH, SERIOUS INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. 4. THE SAMPLE WAS A SERUM SAMPLE. QUALITY CONTROL (QC) RESULTS AND CALIBRATION RESULTS DEMONSTRATED ACCEPTABLE RECOVERY. ASSAY PRECISION ASSESSMENTS INDICATED PRECISION WAS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CALCIUM ARSENAZO