BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2222351 · Received August 25, 2011

    Report

    Report Number
    2050012-2011-04822
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER COMPLAINT RECORD, QC PRIOR TO AND AFTER THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND A DIRTY LINE IN THE SYSTEM, A SMALL PIECE OF RUBBER IN THE ELECTROLYTE INJECTION CUP (EIC) VALVE, AND A DAMAGED POTASSIUM (K) ELECTRODE COLLAR. THE FSE REPLACED THE DAMAGED PARTS AND PERFORMED ISE MODIFICATIONS PRIOR TO RETURNING IT INTO SERVICE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED SEVERAL FALSE HIGH SODIUM (NA) RESULTS. SOME OF THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE SAMPLES WERE REPEATED, ON AN ALTERNATE INSTRUMENT, AND SOME RESULTS WERE AMENDED. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THIS REPORT. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE FALSE RESULTS REPORTED.

    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