BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1908461 · Received November 27, 2010

    Report

    Report Number
    2050012-2010-01422
    Event Type
    Malfunction
    Date Received
    November 27, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 29, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JFM
    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 SAMPLE WAS ANALYZED FROM THE PRIMARY TUBE. QC WAS TRENDING DOWNWARDS. NO OTHER SYSTEM ERRORS WERE NOTED AND THE CUSTOMER CONFIRMED NO OTHER CHEMISTRIES WERE AFFECTED. ON (B)(4) 2010, A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE REAGENT AND SAMPLE SYRINGES. THE FSE FOUND 3 BROKEN CUVETTES, GLASS IN ONE WASH/VACUUM PROBE, AND VACUUM LEAK AT WASH MANIFOLD. THE FSE REPLACED THE WHOLE WASH MANIFOLD ASSEMBLY, AND PERFORMED ALIGNMENTS. THE FSE CALIBRATED BOTH TBIL AND DBIL (DIRECT BILIRUBIN) AND PERFORMED 20 REP PRECISION TESTS ON BOTH CHEMISTRIES. ALL RESULTS WERE WITHIN THE SPECIFICATIONS. THE ROOT CAUSE FOR THIS EVENT WAS HARDWARE. THIS REPORT IS LINKED TO MEDWATCH REPORTS #2050012-2010-01419 AND 2050012-2010-01421.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY LOW TOTAL BILIRUBIN (TBIL) RESULT GENERATED BY UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON AN ALTERNATE ANALYZER PRODUCED HIGHER RESULT. THERE WAS NO EFFECT TO THE PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1