BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2251970 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-04925
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THAT THE VACUUM FOR THE CAP PIERCER WASTE WAS NOT ACTIVATING. THE FSE REPAIRED THE ANALYZER AND VERIFIED ANALYZER PERFORMANCE PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT ERRONEOUSLY LOW RESULTS FOR SEVERAL ANALYTES FOR ONE (1) PATIENT SAMPLE ON A UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT. WHEN THE ERRONEOUS RESULTS WERE DISCOVERED, THE CUSTOMER ASSAYED THE PATIENT SAMPLE ON THE OTHER UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER IN THE LABORATORY. THESE PATIENT SAMPLE RESULTS WERE INTERPRETED TO BE CORRECT AND WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED OBSERVING AUTOGLOSS SOLUTION LEAKING FROM THE CAP PIERCER IN THE ANALYZER. AUTOGLOSS IS A NON-HAZARDOUS SOLUTION. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE -- LAB COAT AND GLOVES) AT THE TIME OF DISCOVERING THE LEAK. THERE WAS NO EXPOSURE TO THE CUSTOMER AND NO REPORTED INJURY. THE CUSTOMER REPORTED HAVING THE MATERIAL SAFETY DATA SHEET (MSDS) FOR AUTOGLOSS. THE CUSTOMER REPORTED HAVING A HAZARD MANAGEMENT PLAN IN PLACE FOR THE FACILITY.

    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