BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2243989 · Received August 19, 2011

    Report

    Report Number
    2122870-2011-02965
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    August 25, 2008
    Report Date
    August 27, 2008
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DECLINED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE CUSTOMER STATED SAMPLES NO LONGER PRODUCED FALSE RESULTS. THE CUSTOMER REPORTED QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS AND AFTER SWITCHING TO A NEW REAGENT PACK, THERE WERE NO FURTHER ISSUES. THE CUSTOMER DID NOT REPORT ANY CHANGE IN LABORATORY PRACTICES. THE CUSTOMER STATED FURTHER DATA WILL NOT BE PROVIDED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(6) 2008 THROUGH (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MEDWATCH REPORTED IS RELATED TO MDRS 2122870-2011-00294 AND 2122870-2011-02995.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED CANCER ANTIGEN (CA) 19-9 RESULTS FOR 2 PATIENTS INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THIS REPORT REFERS TO PATIENT NUMBER 1. THE ELEVATED RESULT WAS NOT RELEASED OUT OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR ACCESS GI MONITOR