BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2101148 · Received May 24, 2011

    Report

    Report Number
    2050012-2011-01897
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 26, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN ESTABLISHED RANGES BEFORE THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS EVENT. ROOT CAUSE IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM GENERATED ONE ERRONEOUS HIGH GLUCOSE (GLUM) RESULT. THE SPECIMEN WAS RE-TESTED AND REPEATED RESULT WAS REPORTED OUT OF THE LAB. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB. THERE WAS NO CHANGE TO PATIENT TREATMENT OR DIAGNOSIS.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1