BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2233747 · Received September 3, 2011

    Report

    Report Number
    2050012-2011-04954
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 TO ADDRESS THIS ISSUE. THE FIELD SERVICE ENGINEER REPLACED THE VACUUM WASTE VALVE ON REAGENT PROBE A. A SUBSEQUENT ANALYTE QUALITY CONTROL ASSESSMENT GENERATED RESULTS THAT WERE WITHIN ESTABLISHED SPECIFICATIONS. UPON COMPLETION OF THE REPAIRS THE INSTRUMENT WAS RETURNED INTO SERVICE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY HAD IDENTIFIED A FLUID LEAK FROM THE REAGENT PROBE A OF AN UNICEL DXC 800 SYNCHRON SYSTEM WHEN THE INSTRUMENT WAS SITTING IDLE. WHEN IN OPERATION THE LEAK WOULD CEASE. THE CUSTOMER INTERFACED WITH THE MACHINE WHILE WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT AND DISCOVERED THE LEAK. THERE WAS NO HEALTHCARE WORKER EXPOSURE OF UNCOVERED WOUNDS OR MUCOUS MEMBRANES TO BIOHAZARDOUS MATERIAL AND NO INJURIES WERE REPORTED. NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. CUSTOMER SUPPLIED DATA INVOLVED TWO PATIENT RESULTS. ONE OF THE PATIENT RESULTS WAS NOT QUESTIONED BY THE CUSTOMER. THE OTHER PATIENT RESULT WAS POTENTIALLY IMPACTED BY THE LEAK. THE RESULT IN QUESTION INVOLVED AN ERRONEOUSLY HIGH ALANINE TRANSAMINASE (ALT) RESULT WHICH WAS GENERATED BY THE INSTRUMENT DURING THE TIMEFRAME OF THE LEAK. WHEN THE SAMPLE WAS REPEATED ON ANOTHER INSTRUMENT THE RESULT WAS LOWER. AN AMENDED REPORT WAS NOT ISSUED BECAUSE, PER THE CUSTOMER, THE DIFFERENCE IN ALT RESULTS WAS NOT ENOUGH TO WARRANT IT AS BOTH RESULTS WERE HIGHLY ELEVATED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. ALL OTHER RESULTS DATA PROVIDED BY THE CUSTOMER APPEARED TO CORRELATE WITH ACCEPTABLE PRECISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1