BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1445206 · Received August 21, 2009

    Report

    Report Number
    2050012-2009-00093
    Event Type
    Malfunction
    Date Received
    August 21, 2009
    Date of Event
    August 13, 2009
    Report Date
    August 21, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN VACUTAINER TUBES, AND SPUN AT 3,500 FOR 10 MINUTES. NO SPECIFIC SAMPLE ISSUES WERE NOTED. THE CUSTOMER RUNS QC EVERY SHIFT AND THIS HARDWARE PROBLEM OCCURRED MID SHIFT, SO WAS NOT DETECTED BY QC. CUSTOMER NOTICED A LEAKING FLUID FROM THE REGION OF THE SAMPLE PROBE AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: A) THE FSE REPLACED THE VALVE WHICH WAS CAUSING LEAKAGE OF FLUID INTO CUPS. B) THE FSE VERIFIED OPERATION OF THE INSTRUMENT. 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 ERRONEOUSLY LOW CREATININE (CREM) RESULTS GENERATED BY THE UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS. BASED ON AVAILABLE INFORMATION, ABOUT 15-20 LOW CREM RESULTS WERE REPORTED OUT OF THE LAB. AFTER INSTRUMENT REPAIR, THE SAMPLES WERE RE-TESTED AND RESULTS WERE AMENDED. CUSTOMER PROVIDED EXAMPLE RESULTS. PER CUSTOMER, THERE WAS NO AFFECT TO PATIENT CARE, DUE TO THESE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1