BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2243966 · Received August 19, 2011

    Report

    Report Number
    2122870-2011-02969
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    August 29, 2008
    Report Date
    August 31, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DECLINED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. ELECTROCARDIOGRAM (ECG) RESULTS WERE NEGATIVE. THE PHYSICIAN DIAGNOSED THE PT WITH PERICARDITIS AND INITIATED TREATMENT. THE CUSTOMER STATED THE DIAGNOSIS IS NOT ASSOCIATED WITH THE ELEVATED TROPONIN I RESULT FOR THIS EVENT. TESTING PERFORMED BY BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB CONFIRMED THE EXISTENCE OF A PT SOURCE INTERFERENT FOR THE PT SAMPLE RECEIVED FROM THE CUSTOMER. THE INTERFERENCE LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND CAUSES REPRODUCIBLE FALSE POSITIVE RESULTS, BUT IS DISTINCT FROM HETEROPHILE ANTIBODIES. PRODUCT LABELING: FOR ANALYSIS 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. THE ACCESS 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 ADDITIONAL TESTS, AND OTHER APPROPRIATE INFO. MEDICAL DECISIONS SHOULD NOT BE BASED ON 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 ADDITIONAL REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2011-02968.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF, FOR ONE PT ON MULTIPLE SAMPLES INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THIS IS REPORT NUMBER TWO OF TWO REFERENCING SYSTEM SERIAL NUMBER (B)(4). THE ELEVATED RESULTS WERE RELEASED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. THERE WAS NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. WITH THE PT SAMPLES 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 21 YR ACCESS ACCUTNI