BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2827928 · Received November 12, 2012

    Report

    Report Number
    2050012-2012-01834
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE VISUALLY INSPECTED THE A/B VALVES, THE SWITCH ASSEMBLY, REAGENT PROBES AND COLLAR WASH ASSEMBLIES. THE FSE FOUND THE REAGENT PROBE TUBING FROM THE WASH BEAD TO THE A/B VALVE WERE INCORRECTLY ROUTED CAUSING MOTION ERRORS. THE FSE RE-ROUTED THE TUBING AND PERFORMED A PRIME. QC AND SAMPLES WERE TESTED. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES, AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE FSE WAS NOT ABLE TO FIND A CAUSE FOR THE LEAKING PROBES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED A LEAK FROM REAGENT PROBES A AND B ON THEIR UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER DID NOT REPORT FLAGS OR ERROR MESSAGES AROUND THE TIME OF THE LEAKING. THE LEAK WAS ABOUT 50 ML AND WAS CONTAINED ON TOP OF THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES, FACE SHIELD AND A LAB COAT. NO INJURIES WERE SUSTAINED BY ANY LAB PERSONNEL. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1