BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1956171 · Received January 10, 2011

    Report

    Report Number
    2050012-2011-00114
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 10, 2010
    Report Date
    December 13, 2010
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION WAS SUPPLIED INDICATING THAT THE INSTRUMENT WAS NOT PERFORMING AS EXPECTED. SERVICE WAS NOT NOTIFIED. THE MALFUNCTION AND ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING TWO (2) ERRONEOUSLY HIGH AMYLASE (AMY) PATIENT RESULTS THAT WERE GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE TWO (2) PATIENTS WERE HOSPITALIZED FOR FIVE (5) DAYS. ON THE FOURTH DAY BOTH PATIENTS HAD A HIGH AMY RESULT OF 936 IU/L AND 970 IU/L, RESPECTIVELY. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE FOLLOWING DAY, THEIR BLOOD DRAWN TESTS WERE BACK TO THEIR TYPICAL RESULTS. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1