BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2233855 · Received September 4, 2011

    Report

    Report Number
    2122870-2011-03157
    Event Type
    Malfunction
    Date Received
    September 4, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A 16X100 BD SERUM TUBE AND WAS CENTRIFUGED FOR 5 MINUTES AT 5000 RPMS. PER THE CUSTOMER, THE TOTAL BHCG QC WAS WITHIN CUSTOMER'S ESTABLISHED RANGES. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A FALSE POSITIVE TOTAL BETA - HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT ON ONE PATIENT'S SAMPLE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. A SUBSEQUENT SAMPLE FROM THE PATIENT RESULTED WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH 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 74 YR