BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1618035 · Received March 1, 2010

    Report

    Report Number
    2050012-2010-00082
    Event Type
    Malfunction
    Date Received
    March 1, 2010
    Date of Event
    February 4, 2010
    Report Date
    March 1, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN BD, PLASTIC GREEN-TOP TUBES. NO SAMPLES ISSUES WERE NOTED. QC AND CALIBRATION WAS NOT AFFECTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE SERVICED THE INSTRUMENT AND REPLACED MULTIPLE HARDWARE COMPONENTS. THE FSE PERFORMED A PRECISION RUN ON BUN AND ALB WITH GOOD RESULTS. THE SYSTEM IS OPERATING ACCEPTABLY NOW. UPON RECUR, THE HARDWARE FAILURES COULD CAUSE ERRONEOUS RESULTS ON ANY OR ALL CARTRIDGE CHEMISTRIES (CC), INCLUDING PIVOTAL CHEMISTRIES. TREATMENT COULD BE INITIATED OR WITHHELD BASED ON THE ERRONEOUS RESULTS OF PIVOTAL CHEMISTRIES THAT MAY CAUSE OR CONTRIBUTE TO SERIOUS INJURY TO THE PATIENT. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY LOW CARTRIDGE CHEMISTRIES (BUN AND ALBUMIN)L RESULTS GENERATED BY THE UNICEL DXC 600 SYNCHRON CLINICAL SYSTEMS. THE LOW RESULTS WERE REPORTED OUT OF THE LAB. THE SPECIMENS WERE RE-TESTED AND HIGHER RESULTS WERE OBTAINED FOR BOTH ANALYTES. THE LABORATORY HAS NOT HEARD OF ANY EFFECT TO PATIENTS; MOST OF THE RESULTS WERE CAUGHT WITH DELTA CHECK OR QUESTIONED BY PHYSICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600

    Patients

    Seq Age Sex Outcome Treatment
    1