BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2240469 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05275
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS DRAWN IN A BECTON DICKINSON VACUTAINER TUBE AND WAS FRESH WHEN IT WAS ASSAYED ON THE ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE REPLACED THE SAMPLE PROBE, THE REAGENT TUBING ON THE A/B VALVE, AND THE TUBING FROM THE REAGENT PROBE TO THE A/B VALVE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT ONE (1) ERRONEOUSLY LOW TOTAL PROTEIN (TP) RESULT GENERATED ON THEIR UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS PATIENT RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE ANALYZER GENERATED AN "OIR LOW" FLAG WHEN ASSAYING THE PATIENT SAMPLE FOR TP. THE PATIENT SAMPLE WAS RE-ASSAYED FOR TP AND AN EXPECTED RESULT WAS OBTAINED. THE CUSTOMER REPORTED THAT QUALITY CONTROL (QC) RESULTS WERE WITHIN ESTABLISHED RANGES PRIOR TO THE EVENT. AFTER THE EVENT, THE CUSTOMER REPORTED THAT QC RESULTS FOR SEVERAL ANALYTES WERE OUTSIDE OF THEIR ESTABLISHED RANGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1