BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER

    MDR report key: 1198925 · Received October 8, 2008

    Report

    Report Number
    2050012-2008-00060
    Event Type
    Other
    Date Received
    October 8, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC SAMPLE INFO WAS PROVIDED. IT IS UNK IF QC WAS AFFECTED. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND REPLACED THE TRAVELER ASSEMBLIES FOR THE RIGHT AND LEFT REAGENT PROBE CRANES. THESE PARTS ARE BEING RETURNED FOR INVESTIGATION. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY LOW CREATININE (CRE) RESULT PRODUCED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER FOR ONE PT. THE ORIGINAL RESULT FOR CRE WAS "<0.3"MG/DL. THE SAMPLE WAS REPEATED ON A DIFFERENT ANALYZER AND THE RESULT WAS 0.8 MG/DL. THE RESULT WAS AMENDED. THERE WAS NO CHANGE TO PT TREATMENT AS A RESULT OF 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA