BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2211678 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02627
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    April 1, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS AND RUN DAILY. SYSTEM CHECK PERFORMED ON 03/20/2008 PASSED WITHIN SPECIFICATIONS. TESTING AT BECKMAN COULTER (B)(4) LABORATORY CONFIRMED THE PRESENCE OF INTERFERING SUBSTANCES IN THE PT SAMPLE. IT IS CONCLUSIVE THE ERRONEOUS RESULTS WERE FALSELY LOW DUE TO INTERFERING SUBSTANCES IN THE PT BLOOD. PRODUCT LABELING: FOR ASSAYS EMPLOYING MOUSE ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HUMAN ANTI-MOUSE ANTIBIOTICS (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 PATIENT SAMPLES. THE ACCESS FREE T4 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 FROM 01/01/2008 THROUGH 10/23/2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE AFFILIATE ALLEGED THE CUSTOMER REPORTED ERRONEOUS FREE THYROXINE (FT4) RESULTS FOR ONE PT INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULTS WERE ZERO AND DID NOT CORRELATE WITH THE PT'S CLINICAL DIAGNOSIS. THE ERRONEOUS RESULTS WERE DISCORDANT TO TWO ALTERNATE METHODOLOGIES. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PT INJURY. THERE WAS NO REPORT OF A CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. IN (B)(6) WITH THE PATIENT 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 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM| ACCESS FREE T4