BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1842982 · Received September 23, 2010

    Report

    Report Number
    2122870-2010-00555
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A PLASTIC SERUM TUBE WITHOUT A GEL SEPARATOR. THE SAMPLE WAS NORMAL IN APPEARANCE. QC RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRE AND POST THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) VERIFIED WASH ARM PERFORMANCE, FLUIDICS CONNECTIONS AND THE DUCK BILL VALVE AND NO ISSUES WERE NOTED. FSE PERFORMED HIGH SENSITIVITY (HS) SYSTEM CHECK, ROUTINE SYSTEM CHECK AND CARRYOVER TEST AND ALL TESTS PASSED WITHIN INSTRUMENT SPECIFICATIONS. FSE DID NOT NOTICE ANY HARDWARE ISSUES WITH THE INSTRUMENT. A CLEAR ROOT CAN NOT 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 ACCESS CHEMISTRY ANALYZER. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE SAME UNIT AND ON ANOTHER UNIT AND NEGATIVE RESULTS WERE 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 DHA BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1