BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2251951 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-04922
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE OBSERVED WATER UNDERNEATH REAGENT PROBE A. FURTHER INVESTIGATION REVEALED THAT THE VACUUM VALVE FOR REAGENT PROBE A WAS STUCK IN THE CLOSED POSITION. THE FSE REPLACED THE VALVE AND PRIMED THE ANALYZER TO VERIFY PROPER VACUUM.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT ERRONEOUSLY LOW RESULTS FOR CREATININE FOR THREE (3) PATIENT SAMPLES ON A UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE PATIENT SAMPLE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ORDERING PHYSICIAN QUESTIONED THE RESULTS. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE CUSTOMER REPORTED THAT QUALITY CONTROL (QC) RESULTS WERE RECOVERING LOW BUT STILL WITHIN THE LABORATORY'S ESTABLISHED RANGES. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLES WERE ASSAYED ON ANOTHER ANALYZER IN THE LABORATORY. THE RESULTS FROM THE OTHER ANALYZER WERE INTERPRETED TO BE CORRECT AND WERE REPORTED OUT OF THE LABORATORY AS AMENDED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1