BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2161021 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01818
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    March 1, 2007
    Report Date
    October 18, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER'S CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY RECEIVED THE PATIENT FOR INVESTIGATION. CPLS TESTED THE SAMPLE AND OBTAINED A NEAT CONCENTRATION OF 1.71 NG/ML AND 1.93 NG/ML. THE DILUTION STUDIES DOES NOT SHOW LINEAR RECOVERY INDICATING THE POSSIBILITY OF SOME KIND OF INTERFERENCE IN THE SAMPLE, BUT THE ADDITION OF IN-HOUSE "INTERFERENCE ELIMINATING PROTEINS" DID NOT AFFECT THE NEAT DOSE RECOVERY. THE RESULTS FROM DIFFERENT SYSTEMS CAN VARY DUE TO ANTIBODY SPECIFICITIES, ASSAY FORMAT AND FORMULATIONS RESULTING IN SUCH RARE CASES OF ERRATIC RESULTS. NO SAMPLE REMAINING FOR FURTHER INVESTIGATION. CPLS WAS UNABLE TO CONFIRM HETEROPHILE PRESENCE OR INTERFERING SUBSTANCE WITH THE SAMPLE TESTED. 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 MDR 2122870-2011-01900. PRODUCT LABELING: 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 PATIENTS 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. IN ADDITION, ELEVATED TROPONIN-I LEVELS HAVE ALSO BEEN DOCUMENTED IN CASES IN OTHER CARDIAC CONDITIONS SUCH AS UNSTABLE ANGINA, CONGESTIVE HEART FAILURE, OR MYOCARDITIS, OR SEVERE NON-CARDIAC CONDITIONS SUCH AS TRAUMA OR RENAL FAILURE THAT MAY CAUSE CARDIAC MUSCLE INJURY. THUS TROPONIN (ACCUTNI) RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFORMATION. MEDICAL DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCUTNI DETERMINATION AT ONE POINT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILED EXTERNAL SURVEY TESTOSTERONE RESULTS FOR ONE FRESH PATIENT SERUM SAMPLE INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THIS IS REPORT NUMBER ONE OF TWO. THE CUSTOMER REPORTED THE RESULTS TO QMP-LS SURVEY GROUP. A SECOND SAMPLE OBTAINED FROM QMP-LS SURVEY GROUP ALSO PRODUCED HIGH RESULTS. THE CUSTOMER SENT PATIENT SAMPLE TO BECKMAN COULTER, INC. FOR FURTHER ANALYSIS. THE EVENT WAS ISOLATED TO A SURVEY SAMPLE. THERE WAS NO PATIENT CONSEQUENCE.

    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 TESTOSTERONE