BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1781450 · Received August 3, 2010

    Report

    Report Number
    2050012-2010-00510
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND FOUND THAT THE TUBING AND THE BUFFER SUPPLY LINE TO THE RATIO PUMP WAS DISCONNECTED. IT WAS RECONNECTED AND A PREVENTIVE MAINTENANCE (PM) WAS COMPLETED. THERE WERE NO FURTHER CALLS REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH NA RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE PATIENT RESULTS WERE REQUESTED FROM THE CUSTOMER BUT NOT SUPPLIED. THERE WAS NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1