BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1900806 · Received November 16, 2010

    Report

    Report Number
    2050012-2010-01159
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    September 30, 2010
    Report Date
    November 16, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE CALL WAS INITIATED OR REQUESTED. THE LOCAL BCI FIELD SERVICE ENGINEERS CONTINUE TO MONITOR THIS ACCOUNT. A ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO DISCORDANT DUPLICATE GLUCOSE (GLUCM) RESULTS GENERATED BY UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 87 MG/DL AND THE RE-RUN RESULT WAS 101 MG/DL. THE RESULT OF 101 MG/DL WAS REPORTED. THERE WAS NO EFFECT TO THE PATIENT OR TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1