BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2171144 · Received July 1, 2011

    Report

    Report Number
    2122870-2011-02081
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    December 4, 2007
    Report Date
    February 7, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 SAMPLES WERE SERUM. ALL OTHER THYROID TESTS PRODUCED RESULTS WITHIN THE NORMAL RANGE. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB RECEIVED ONE SAMPLE FROM THE CUSTOMER THAT APPEARED HEMOLYSED. CPLS TESTING GAVE A NEAT TT3 CONCENTRATION OF 4.22 NG/ML. THE DILUTION TESTING SHOWED NON-LINEAR RECOVERY INDICATING THAT THERE MAY BE SOME KIND OF INTERFERENCE, BUT ADD'L HETEROPHILE TESTING HAD NO SIGNIFICANT EFFECT ON THE NEAT DOSE RECOVERY OF THE PT SAMPLE. THE ROOT CAUSE OF THE PT'S ELEVATED RESULT MAY BE DUE TO SOME KIND OF INTERFERENCE BUT COULD NOT BE CONFIRMED. THE ROOT CAUSE OF THE ELEVATED RESULTS IS UNK. 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 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. 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 I (ACCU TNI) RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PT, INCLUDING SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADD'L TESTS, AND OTHER APPROPRIATE INFO. MEDICAL DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCU TNI DETERMINATION AT ONE TIME POINT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(6), 2008 THROUGH (B)(6), 2010 FOR ADD'L REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDRS: 2122870-2011-02078 AND 2122870-2011-02082.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED SERUM TOTAL TRIIODOTHYRONINE (TT3) RESULTS FOR ONE PT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THIS IS REPORT NUMBER TWO OF THREE. IT IS UNK IF THE ELEVATED RESULTS WERE REPORTED OUT OF THE LAB. 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 UNK ACCESS TOTAL T3