BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AUTOMATED CLINICAL CHEMISTRY ANALYZER

    MDR report key: 421825 · Received October 10, 2002

    Report

    Report Number
    8010047-2002-00093
    Event Type
    Malfunction
    Date Received
    October 10, 2002
    Report Date
    October 10, 2002
    Manufacturer
    OLYMPUS OPTICAL CO., LTD., SAN-EI BUILDING
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORT OF ANALYZER MALFUNCTION DURING OPERATION. IF THE ANALYZER IS OPERATING IN A SAMPLE MEASUREMENT MODE AND THE CUSTOMER IS UTILIZING THE SEQUENTIAL (NON-BARCODED SAMPLES) SAMPLE IDENTIFICATON MODE, AND DATA IS EDITED USING THE ANALYZER SOFTWARE FEATURE, A DATABASE CONFLICT MAY OCCUR WHICH MAY RESULT IN ONE SAMPLE NUMBER BEING USED FOR TWO SEPARATE SAMPLE TEST RESULTS. THERE IS NO POTENTIAL FOR THIS EVENT IF THE ANALYZER STATUS IS STOP, PAUSE, OR STAND-BY, WHICH COULD RESULT IN A SAMPLE CONCORDANCE ERROR. THERE WERE NO INJURIES REPORTED.

    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., SAN-EI BUILDING AU2700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other