BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AUTOMATED CLINICAL CHEMISTRY ANALYZER

    MDR report key: 420032 · Received October 1, 2002

    Report

    Report Number
    8010047-2002-00087
    Event Type
    Malfunction
    Date Received
    October 1, 2002
    Report Date
    October 1, 2002
    Manufacturer
    OLYMPUS OPTICAL CO., LTD.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FOREIGN CUSTOMER REPORT OF ANALYZER MALFUNCTION DURING OPERATION. IF LIH (LIPEMIA, ICTERUS, HEMOLYSIS) TESTING IS SWITCHED FROM USE OF A DEDICATED SALINE REAGENT TO THE USE OF AN EXISTING R1 CHEMISTRY REAGENT FOR LIH TESTING, THEN THE ANALYZER WILL CONDUCT A CHEMISTRY TEST CORRESPONDING TO THE ORDINAL PLACEMENT OF THE LIH TEST REQUISTION USING THE TEST PARAMETERS PROGRAMMED FOR A DIFFERENT CHEMISTRY TEST ASSAY; POTENTIALLY RESULTING IN ERRONEOUS RESULTS. THERE IS NO POTENTIAL FOR THIS EVENT IF THE USE OF A DEDICATED REAGENT FOR LIH TESTING IS CONTINUOUSLY USED. THERE HAVE BEEN NO REPORTS OF THIS SITUATION OCCURRING IN THE UNITED STATES, AND THERE WERE NO INJURIES REPORTED BY THE FOREIGN REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AUTOMATED CLINICAL CHEMISTRY ANALYZER AUTOMATED CLINICAL CHEMISTRY ANALYZER JJE OLYMPUS OPTICAL CO., LTD. AU2700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other