BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1882915 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01082
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) VISITED AND REPLACED THE STIRRER MOTOR AND REAGENT SYRINGE PUMP. THIS RESOLVED THE ISSUE, PARTS HAVE BEEN REQUESTED TO BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING 3 HIGH RESULTS REPORTED FOR BUN GENERATED BY THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. THERE WAS NO AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1