BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1932654 · Received December 20, 2010

    Report

    Report Number
    2050012-2010-01690
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE RAN IN PLASMA TUBES FROM THE AUTOMATION LINE. QC HAD BEEN RUNNING WITHIN ACCEPTABLE ESTABLISHED SPECIFICATIONS PRIOR TO THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FLUSHED THE GLUCOSE CUP AND ASSOCIATED TUBING LINES THE DAY BEFORE THE EVENT. THE FSE ALSO REPLACED THE REAGENT SYRINGE PUMP AND SAMPLE SYRINGE. ROOT CAUSE IS UNKNOWN TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING TWO (2) GLUCOSE (GLU) PATIENT SAMPLES DID NOT MATCH WHEN RUN IN DUPLICATE MODE THAT WAS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ORIGINAL RESULTS WERE ERRONEOUSLY LOW. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1