BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2924607 · Received January 22, 2013

    Report

    Report Number
    2050012-2013-00049
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE IDENTIFIED THAT ALL THE LEAKING FLUID WAS CONTAINED BY THE DESIGNED DRIP CHANNELS AND GRAVITY DRAIN. THE FSE INDICATED THAT THE CARTRIDGE CHEMISTRY (CC) WASH COLLAR WAS NOT FULLY INSERTED INTO THE WASH COLLAR HOLDER AND WAS TOO LOW; MEANING THAT NO VACUUM WAS SEALED TO THE WASH COLLAR. THE FSE REPLACED THE VACUUM VALVE, THE CC SAMPLE PROBE, AND THE WASH COLLAR, WHICH RESOLVED THE ISSUE. SYSTEM PERFORMANCE WAS ALSO VERIFIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A CONTAINED CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE LEAK IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE LEAK WAS OBSERVED FROM THE CC SAMPLE PROBE WASH COLLAR WHILE RUNNING SAMPLES. AS THE CC SAMPLE PROBE WAS BEING WASHED, FLUID WOULD SQUIRT FROM THE WASH COLLAR. THE CUSTOMER INDICATED THAT APPROXIMATELY 15 MLS LEAKED FROM THE INSTRUMENT. THE CUSTOMER WAS WEARING PROPER PROTECTIVE EQUIPMENT (PPE), INCLUDING GLOVES AND LABORATORY COAT WHEN THE LEAK WAS DISCOVERED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. THE CUSTOMER INDICATED THAT FIVE (5) PATIENTS GENERATED ERRONEOUS RESULTS ON MULTIPLE TESTS DUE TO THE LEAK. THE PATIENT SAMPLES WERE RERUN ON AN ALTERNATE BACKUP INSTRUMENT IN THE CUSTOMER'S LABORATORY. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, AMENDED REPORTS WERE SUBMITTED. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THIS REPORT. THERE WAS NO REPORT OF IMPACT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30903 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1