BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2171163 · Received July 1, 2011

    Report

    Report Number
    2122870-2011-02083
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    February 9, 2008
    Report Date
    February 13, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. NO COLLECTION OR CENTRIFUGATION DATA WAS SUPPLIED. SYSTEM CHECK DATA INFO WAS NOT SUPPLIED BY THE CUSTOMER. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS WITHIN SPEC PRIOR TO AND FOLLOWING THE EVENT. H6: CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB TESTED THE PT SAMPLE AND CONFIRMED CIRCULATING HETEROPHILE ANTIBODIES CAUSING INTERFERENCE WITH THE ESTRADIOL RESULT. HETEROPHILE INTERFERENCE IS THE ROOT CAUSE OF THE ERRONEOUS RESULTS. PRODUCT LABELING: THE ACCESS ESTRADIOL RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PT, INCLUDING SYMPTOMS, CLINICAL HISTORY, DATA FROM ADD'L TESTS AND OTHER APPROPRIATE INFO. FOR ASSAYS EMPLOYING MOUSE ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HUMAN ANTI-MOUSE ANTIBODIES (HAMA) IN THE SAMPLE. HUMAN ANTI-MOUSE ANTIBODIES MAY BE PRESENT IN SAMPLES FROM PTS WHO HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING MONOCLONAL ANTIBODIES OR IN INDIVIDUALS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES, SUCH AS HUMAN ANTI-GOAT ANTIBODIES, MAY BE PRESENT IN PT SAMPLES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INDETERMINATE (IND) FLAGS AND ZERO ESTRADIOL RESULTS FOR ONE PT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE RESULTS WERE DISCORDANT TO AN UNK ALTERNATE METHODOLOGY. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. 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 ACCESS 2 IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ESTRADIOL