BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON UNICEL DXC 600PRO CLINICAL SYSTEMS

    MDR report key: 2042746 · Received April 6, 2011

    Report

    Report Number
    2050012-2011-00896
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLB
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN PRIOR TO AND AFTER THE INCIDENT AND ACCORDING TO THE CUSTOMER, THE QC RESULTS WERE ACCEPTABLE. SERVICE WAS NOT REQUESTED. THE CUSTOMER TIGHTENED THE SYRINGE AND ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW CREATINE KINASE (CK) RESULT ON ONE PATIENT GENERATED BY UNICEL DXC 600PRO CLINICAL SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON ANOTHER INSTRUMENT AND HIGHER RESULT WAS OBTAINED. THE REPEAT RESULT MATCHED THE VALUES WHICH THE PATIENT HAS BEEN MEASURED FOR ALL WEEK. UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON UNICEL DXC 600PRO CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JLB BECKMAN COULTER INC. DXC600P N/A

    Patients

    Seq Age Sex Outcome Treatment
    1