BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1585205 · Received January 25, 2010

    Report

    Report Number
    2050012-2010-00022
    Event Type
    Malfunction
    Date Received
    January 25, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 25, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CKA
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A 13X100MM GREINER TUBE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE NOTICED THE SYSTEM GENERATED MULTIPLE "OBSTRUCTION DETECTION" WARNINGS. THE FSE OBSERVED GREY RUBBER IN TUBES AND INSTALLED A NEW BLADE. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT. HOWEVER, UPON RECUR ANY CHEMISTRY COULD BE AFFECTED, INCLUDING PIVOTAL ASSAY. 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. ROOT CAUSE IS UNKNOWN. 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 A FALSE LOW ALANINE AMINOTRANSFERASE (ALT) RESULT GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE INITIAL ALT RESULT OF 4 IU/L WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. CUSTOMER RE-SPUN AND RERAN THE SAMPLE WHICH YIELDED AN ALT RESULT OF 638 IU/L. THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1