BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172503 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01986
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    November 29, 2007
    Report Date
    November 30, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED SERVICE AS THERE WAS NO SYSTEM PERFORMANCE ISSUE. THE SAMPLE WAS DRAWN INTO A PLASMA LIHEP TUBE. THE SAMPLE WAS CENTRIFUGED AT <5,000 RPM (ROTATIONS PER MINUTE) FOR GREATER THAN 5 MINUTES. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION PRIOR TO AND FOLLOWING THE EVENT. SYSTEM CHECK DATA WAS NOT SUPPLIED BY THE CUSTOMER. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY TESTED THE PT SAMPLE AND OBTAINED A TRUE NEGATIVE RESULT FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG). HETEROPHILE ANALYSIS INDICATED THAT THERE WAS NO HETEROPHILE INTERFERENCE IN THE PT'S SAMPLE. THE ROOT CAUSE OF THE EVENT IS UNK. AS INDICATED PER PRODUCT LABELING, THE ACCESS TOTAL BHCG RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFO. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDRS: 2122870-2011-01985 AND 2122870-2011-01991.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONE FALSE POSITIVE BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) PT RESULT INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THIS IS REPORT NUMBER TWO OF THREE. THE FALSE POSITIVE RESULT WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PT INJURY. A CHANGE IN PT TREATMENT WAS NOTED. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. WITH THE PT SAMPLE FOR FURTHER ANALYSIS.

    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 UNK ACCESS TOTAL BHCG