BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2242320 · Received September 10, 2011

    Report

    Report Number
    2050012-2011-04957
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SUPPLEMENTAL SAMPLE INFORMATION WAS PROVIDED. QC HAS BEEN WITHIN ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) SPECIALIST WAS DISPATCHED AND ADJUST THE PHOTOMETER, WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING ONE (1) ERRONEOUSLY HIGH ASPARTATE AMINOTRANSFERASE (AST) PATIENT RESULT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE FIRST SAMPLE GENERATED A RESULT OF 45 IU/L, WHICH WAS REPORTED OUT OF THE LABORATORY. THE SAME SAMPLE WAS RERUN AND GENERATED A LOWER RESULT OF 22 IU/L. A SECOND SAMPLE WAS RUN, FROM THE SAME PATIENT, AND GENERATED A RESULT OF 24 IU/L. THERE WAS NO CHANGE TO PATIENT TREATMENT OR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1