BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3062222 · Received April 16, 2013

    Report

    Report Number
    2050012-2013-00254
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNLOADING WET SAMPLE RACKS AND TUBE CAPS INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER INDICATED THAT THE CAP PIERCER DRAIN OVERFLOWED BUT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, GOGGLES AND A LABORATORY COAT AND NO INJURY WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 AND DISCOVERED PIECES OF CAP CLOGGING THE WASTE VALVE; THE FSE PROCEEDED TO CLEAN THE WASTE VALVE. THE CUSTOMER REPORTED OF THE SAME ISSUE AGAIN AND THE FSE REPLACED THE VALVE ON (B)(4) 2013 TO RESOLVE THE ISSUE. FAILURE MODE IS ATTRIBUTED TO A CLOGGED VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162218 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1