BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1842989 · Received September 23, 2010

    Report

    Report Number
    2122870-2010-00554
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 26, 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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED OFF-SITE IN A 13X100 BD PLASMA TUBE WITH A GEL SEPARATOR AND PROCESSED OFF SITE. QC RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRE AND POST THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWINGS: RAN HIGH SENSITIVITY (HS) SYSTEM CHECK, WHICH CONTAINED FEW FLIERS. REPLACED ASPIRATE PROBE #1, DUCKBILL VALVE, AND DISPENSE PROBES. CLEANED THE CAROUSEL AND ADJUSTED THE UNIT. REPEATED HS SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. TEN POINTS OF QC WERE PERFORMED AND PASSED WITHIN CUSTOMER'S ESTABLISHED RANGES. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE 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) RESULTS GENERATED BY UNICEL DXI 800 ACCESS CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE CLINICIAN. THE SAMPLE WAS REPEATED ON THE ALTERNATE UNIT WHICH PRODUCED A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. AMENDED REPORT WAS INITIATED. 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