BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1932434 · Received December 17, 2010

    Report

    Report Number
    2050012-2010-01603
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS PERFORMING WITHIN CUSTOMER'S ESTABLISHED SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE FLUSHED THE GLUCOSE MODULE, CHECKED THE ELECTRODE, AND MADE AN ALIGNMENT ADJUSTMENT OF THE MODULE TO THE SAMPLE PROBE. THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS OBTAINING EIGHT (8) GLUCOSE (GLUC) PATIENT RESULTS THAT DID NOT MATCH WHEN RAN IN DUPLICATE MODE THAT WERE GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. ORIGINAL SAMPLES AND DUPLICATE MODE RERUNS WERE SEQUENTIAL. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE RESULTS, PROVIDED BY THE CUSTOMER. NO PATIENT RESULTS WERE AFFECTED IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1