BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER

    MDR report key: 1100203 · Received July 30, 2008

    Report

    Report Number
    2050012-2008-00032
    Event Type
    Other
    Date Received
    July 30, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ANALYTES RUN WITH THE OTHER SAMPLES WERE QUESTIONED BY PHYSICIANS. INSTRUMENT STARTED GIVING ERRATIC ADC ERROR MESSAGES FOR CREATININE CHANNEL. CUSTOMER CONTINUED TO RUN SAMPLES. NO ADDITIONAL CALIBRATION OR CONTROLS WERE RUN. CALIBRATION AND CONTROL INSTRUMENT PRINTOUTS WERE ACCEPTABLE PRIOR TO ERROR MESSAGES AND ERRONEOUS RESULTS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER LAB: FSE REPLACED REAGENT TO MODULE TUBING, MC VACUUM REGULATOR, SAMPLE PROBE WITH ALIGNMENTS PERFORMED AND MODULE REPLACED. BCI REP HAS REQUESTED THE MODULE TO BE RETURNED TO BREA BUT IT HAS NOT BEEN RECEIVED TO DATE. 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 ERRONEOUSLY HIGH CREATININE (CRE) TEST RESULTS PRODUCED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER FOR SEVERAL PATIENTS. ONLY ONE EXAMPLE OF THE ERRONEOUS RESULTS WAS PROVIDED. THE ORIGINAL RESULT WAS 4.4MG/DL AND THE CORRECTED RESULT WAS 1.0MG/DL. UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD BUT RESULT WAS QUESTIONED BY THE PHYSICIAN.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA