BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1982041 · Received February 8, 2011

    Report

    Report Number
    2050012-2011-00401
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE SYRINGE FOR THE CREATININE MODULE. THE FSE INSPECTED THE REAT OF THE CUP MODULES AND FOUND THAT THE TOTAL PROTEIN MODULE SYRINGE WAS ALSO LEAKING, WHICH WAS REPLACED. THE FSE CALIBRATED THE CHEMISTRIES AS NEEDED, RAN CUSTOMER QC, AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES. ALL RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER WAS GENERATING REAGENT LEVEL LOW ERRORS ON THE CREATININE MODULE. THE CUSTOMER PULLED UP THE REAGENT MODULE AND SAW THAT THE REAGENT PUMP WAS LEAKING. THE CUSTOMER DISCOVERED DRIED REAGENT AROUND THE SYRINGE. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1