BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1634887 · Received March 18, 2010

    Report

    Report Number
    2050012-2010-00124
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 18, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS PERFORMED BEFORE THE EVENT WITH ACCEPTABLE RESULTS. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED. PER FOLLOW-UP CALL, CUSTOMER STATED THE PATIENT HAS BEEN MONITORED FOR CK RESULTS OVER 2 WEEKS PERIOD, AND THE PATIENT'S CK RESULTS RANGE FROM 25-50 IU/L. THEREFORE, THE 37 IU/L RESULT AGREES WITH THE PATIENT'S HISTORICAL RESULTS. 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 A SUPPRESSED OIR LOW CREATINE KINASE (CK) RESULT GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE LAB OBTAINED A SUPPRESSED OIR LO CK RESULT FROM A NEAT SAMPLE. THE SPECIMEN WAS DILUTED WITH A KNOWN BIORAD 1 CONTROL AND A RESULT OF 36 IU/L WAS GENERATED (MANUAL CALCULATION BY THE CUSTOMER). THE CUSTOMER CONFIRMED THE RESULT BY DILUTING THE NEAT SAMPLE WITH SALINE WHICH YIELDED A RESULT OF 37 IU/L. THE RESULT WAS REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED IN CONNECTION TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1