BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2171168 · Received July 1, 2011

    Report

    Report Number
    2122870-2011-02062
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 7, 2007
    Report Date
    January 7, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. SYSTEM CHECK DATA AND SAMPLE INFO WERE NOT PROVIDED BY THE CUSTOMER. PT SAMPLE WAS NOT SUPPLIED TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB FOR FURTHER ANALYSIS. THE ROOT CAUSE OF THE EVENT 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 (ACCUTNI) 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. MED DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCUTNI DETERMINATION AT ONE TIME POINT. 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. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2011-02055.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCUTNI) PT RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF FROM ONE PT'S SAMPLES INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THIS IS REPORT NUMBER TWO OF TWO. 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.

    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 ACCUTNI