BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2091506 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01587
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CHECKED THE FITTING ON TOP OF THE PROBE AND REAGENT SYRINGE WHICH WERE NOTED TO BE TIGHT. THE CUSTOMER REPORTED THAT THE PROBLEM WAS RESOLVED HOWEVER CALLED BACK ON (B)(6) 2011 TO REPORT THAT THE PROBLEM CAME BACK. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND REPLACED THE BUBBLE GENERATOR WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING A REAGENT PROBE OF THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM WAS LEAKING. THE LEAK WAS CONTAINED TO THE COVERS. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1