BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1932432 · Received December 17, 2010

    Report

    Report Number
    2050012-2010-01601
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 75% OF ALL PATIENT SAMPLES ARE COLLECTED IN PLASTIC LITHIUM HEPARIN PLASMA TUBES WITH GEL SEPARATOR. 25% OF ALL PATIENT SAMPLES ARE COLLECTED IN SERUM PLASTIC TUBES WITH GEL SEPARATOR. TUBE GEL SEPARATOR MATERIAL WAS FOUND LODGED IN THE MODULAR CHEMISTRY (MC) SAMPLE PROBE AND COLLAR WASH. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE MC SAMPLE PROBE AND COLLAR WASH. ALTHOUGH GEL MATERIAL WAS FOUND IN THE HARDWARE, THE ERRONEOUS RESULTS WERE GENERATED AFTER THE GEL MATERIAL WAS REMOVED AND PARTS REPLACED BY THE FSE. ROOT CAUSE IS UNKNOWN AT THIS TIME AND NO OTHER PARTS WERE REPLACED AFTER THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FOUR (4) GLUCOSE (GLUC) PATIENT RESULTS DID NOT MATCH WHEN RAN ON DUPLICATE MODE THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. A RERUN OF THE ORIGINAL SAMPLE WAS PERFORMED ON THE SAME INSTRUMENT PRIOR TO REPORTING THE RESULT. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE RESULTS, PROVIDED BY THE CUSTOMER. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1