BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2102315 · Received May 25, 2011

    Report

    Report Number
    2050012-2011-01900
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 24, 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. THE CUSTOMER FOUND THAT THERE WAS A LEAKAGE AROUND THE ELECTRODE. THE ELECTRODE AND THE RETAINER NUT WERE REPLACED AND THE LEAKAGE STOPPED. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT ERRONEOUSLY HIGH GLUCOSE (GLUCM) RESULTS WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE SPECIMENS WERE RE-TESTED AND REPEATED RESULTS WERE REPORTED OUT OF THE LAB. NO ERRONEOUS RESULTS WERE 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