BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2230161 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04778
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC AT THE TIME OF THE EVENT WAS SHOWING IMPRECISION AND HIGH RECOVERY.THE CUSTOMER FOUND THAT THE MODULAR CHEMISTRY (MC) SAMPLE PROBE WAS PLUGGED WITH A PIECE OF RED RUBBER. CLEANING THE PROBE RESOLVED THE ISSUE.A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE, EVALUATED THE INSTRUMENT AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED FALSE HIGH SODIUM (NA) AND CHLORIDE (CL) RESULTS. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. WHEN QC IDENTIFIED A PROBLEM, APPROXIMATELY 130 SAMPLES WERE RERUN ON A DIFFERENT INSTRUMENT IN THE LABORATORY AND THOSE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT. THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1