BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1932305 · Received December 17, 2010

    Report

    Report Number
    2122870-2010-00905
    Date Received
    December 17, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED AT A SATELLITE FACILITY IN A PLASTIC BD SERUM TUBE WITH A GEL SEPARATOR. THE SAMPLE WAS NORMAL IN APPEARANCE. ALL THREE LEVELS OF BHCG QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR AND POST THE EVENT. THE CUSTOMER STATED TO THE CUSTOMER TECHNICAL SUPPORT NO HARDWARE ISSUES WERE NOTED IN CONJUNCTION WITH THIS EVENT. SERVICE WAS NOT DISPATCHED SINCE THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE. A CLEAR ROOT CAUSE CAN BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUSLY FALSE POSITIVE BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT GENERATED BY UNICEL DXI 800 ACCESSS CHEMISTRY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE ORIGINAL SAMPLE AS WELL AS A SECOND SAMPLE WERE TESTED AND LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR