BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172246 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01991
    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
    K922823/A007
    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 PATIENT SAMPLE AND OBTAINED A TRUE NEGATIVE RESULT FOR BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG). HETEROPHILE ANALYSIS INDICATED THAT THERE WAS NO HETEROPHILE INTERFERENCE IN THE PATIENT'S SAMPLE. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. AS INDICATED PER PRODUCT LABELING, THE ACCESS TOTAL BHCG RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFORMATION. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM JANUARY 01, 2008 THROUGH OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDRS: 2122870-2011-01985 AND 2122870-2011-01986.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONE FALSE POSITIVE BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG) PATIENT RESULT ORIGINALLY GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THIS REPORT REFERS TO THE REPEATED RESULT GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM. REPORT NUMBER THREE OF THREE. THE FALSE POSITIVE RESULT WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY. A CHANGE IN PATIENT TREATMENT WAS NOTED. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. WITH THE PATIENT SAMPLE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS TOTAL BHCG