BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2120773 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-01885
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED. QC WAS WITHIN ESTABLISHED RANGES BEFORE THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE CREM MODULE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT FOUR ERRONEOUS CREATININE RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER THE SAMPLES WERE NOT REPORTED OUT OF THE LABORATORY, HENCE NO PATIENT TREATMENT AS IMPACTED. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. AMENDED REPORT WAS INITIATED.

    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