BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2161022 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01797
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    October 10, 2007
    Report Date
    October 29, 2007
    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

    CUSTOMER TECHNICAL SUPPORT (CTS) INFORMED THE CUSTOMER OF THE POTENTIAL BIOHAZARDS AND SAFETY HAZARDS ASSOCIATED WITH TROUBLESHOOTING WHICH MAY INCLUDE A POTENTIAL FOR SHOCK, PUNCTURE OR PINCH AND ADVISED THE CUSTOMER TO REMOVE JEWELRY AND USE PROPERLY INSTALLED TOOLS TO MINIMIZE RISKS. THE CUSTOMER UNDERSTOOD AND AGREED TO CONTINUE TROUBLESHOOTING. CTS GUIDED THE CUSTOMER THROUGH FLUSHING THE VACUUM PUMP, AND THE VACUUM TEST SUCCESSFULLY COMPLETED. THE UNIT WAS RETURNED TO OPERATION. THE SAMPLE IN QUESTION WAS NOT AVAILABLE FOR ADDITIONAL TESTING. ON (B)(6) 2007, THE PATIENT RETURNED TO THE CLINIC AND A SAMPLE WAS PROVIDED TO BECKMAN COULTER, INC. FOR ADDITIONAL TESTING. CLINICAL HISTORY WAS NOT SUPPLIED. SYSTEM CHECK RESULTS FROM (B)(6) 2007 ON SYSTEM (B)(4) WERE SUPPLIED AND ALL RESULTS MET THE MANUFACTURER'S SPECIFICATIONS. QUALITY CONTROL (QC) HISTORY WAS NOT SUPPLIED BY THE CUSTOMER. THE PATIENT SAMPLE WAS FIRST TESTED FOR TROPONIN TO CONFIRM THE CUSTOMER'S RESULT. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY TESTING OBTAINED NEAT CONCENTRATION OF 0.336 NG/ML. A DILUTION RECOVERY WAS PERFORMED. HETEROPHILE TESTING WAS THEN CARRIED OUT AND "HETEROPHILE INTERFERENCE" WAS CONFIRMED IN THIS PATIENT'S SAMPLE. IN CONCLUSION, HETEROPHILE INTERFERENCE IS THE ROOT CAUSE FOR THE DISCORDANT RESULTS. 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 TIME. 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: 2122870-2011-01796.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN (ACCUTNI) PATIENT RESULTS INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER DID NOT KNOW WHICH ACCESS 2 IMMUNOASSAY SYSTEM THE RESULTS OCCURRED ON. THIS IS REPORT NUMBER TWO OF TWO REFERENCING SYSTEM (B)(4). VALUES OBTAINED WERE ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF AND NEGATIVE VIA AN ALTERNATE METHODOLOGY. THE CUSTOMER SUSPECTED HETEROPHILE INTERFERENCE AND STATED THE RESULT DID NOT CORRELATE WITH THE PATIENT'S CLINICAL CONDITION. THE RESULTS WERE REPRODUCIBLE. THE CUSTOMER DID NOT PERFORM ADDITIONAL TESTING TO CONFIRM HETEROPHILE INTERFERENCE. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT 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 52 YR ACCESS ACCUTNI