BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1915630 · Received December 6, 2010

    Report

    Report Number
    2050012-2010-01425
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT A TUBE CAME OFF AFTER A FIELD SERVICE ENGINEER (FSE) WAS THERE TO REPAIR A VACUUM/PRESSURE ISSUE ON THE INSTRUMENT. INVESTIGATION IS STILL ON GOING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING INCORRECT BLOOD UREA NITROGEN (BUN) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS FOR MULTIPLE PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LAB. THE SPECIMENS WERE RE-TESTED AND LOWER RESULTS WERE OBTAINED. ORIGINAL AND REPEATED PATIENT RESULTS ARE SHOWN. PATIENT TREATMENT WAS NOT AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1