BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2223198 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02770
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 8, 2008
    Report Date
    July 10, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE SAMPLE WAS COLLECTED IN A BD SERUM SEPARATION TUBE (SST) AND ALLOWED TO CLOT FOR ONE HOUR. THE SAMPLE WAS CENTRIFUGED AT 3,375 RPM (ROTATIONS PER MINUTE). QUALITY CONTROL IS RUN ONCE DAILY AND WAS WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. TESTING AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB CONFIRMED HETEROPHILE INTERFERENCE IN THE PT SAMPLE. PRODUCT LABELING: FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PT SAMPLE. PTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES E.G HUMAN ANTI-MOUSE ANTIBODIES (HAMA), THAT INTERFERE IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PTS SUSPECTED OF HAVING THESE ANTIBODIES. THE ACCESS PROLACTIN 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. 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 ELEVATED PROLACTIN RESULT FOR ONE PT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE ELEVATED RESULT WAS DISCORDANT TO TWO ALTERNATE METHODOLOGIES WHICH PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS RELEASED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. THERE HAS BEEN 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 52 YR ACCESS PROLACTIN| UNICEL DXI SYSTEM: (UNK MODEL)