BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2223809 · Received August 26, 2011

    Report

    Report Number
    2050012-2011-04887
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 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
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE EITHER SERUM OR PLASMA. NO ADDITIONAL SAMPLING INFORMATION WAS PROVIDED. 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 WAS UNABLE TO REPRODUCE THE ISSUE. WHILE ONSITE, THE FSE REPLACED THE SODIUM (NA) AND CHLORIDE (CL) ELECTRODES AND MADE MINOR ADJUSTMENTS TO REAGENT LINE PLACEMENTS. PERFORMANCE WAS VERIFIED 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 FALSE LOW SODIUM (NA) RESULTS ON THIRTEEN (13) SAMPLES FROM FIVE (5) PATIENTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE SAMPLES WERE REPEATED AND RESULTS AMENDED. 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