BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2161020 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01780
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    October 18, 2007
    Report Date
    October 18, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE EVENT WAS ISOLATED TO A SPECIFIC PATIENT SAMPLE. THE CUSTOMER COLLECTED SAMPLES IN BD LITHIUM HEPARIN NON-GEL TUBES. THE CUSTOMER CENTRIFUGED SAMPLES AT <5000 RPM (ROTATIONS PER MINUTE) FOR 10 MINUTES IN A SWINGING BUCKET CENTRIFUGE. THE SPECIMENS WERE SAMPLED FROM THE PRIMARY TUBES. PATIENT SAMPLE WAS ALSO TESTED ON A BIOSITE TRIAGE METER WHICH PRODUCED <0.05 NG/ML TROPONIN RESULT. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS ON THE DAY OF THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2007 WAS WITHIN SPECIFICATIONS. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY TESTED THE PATIENT SAMPLE AND OBTAINED A NEAT TROPONIN VALUE OF > 100.0 NG/ML. DILUTION STUDIES INDICATE NON-LINEAR RECOVERY, AND THE ADDITION OR HETEROPHILE BLOCKING AGENTS REDUCED THE NEAT DOSE CONCENTRATION SIGNIFICANTLY TO 3.11 NG/ML INDICATING THAT THERE IS "HETEROPHILE INTERFERENCE" IN THE PATIENT'S SAMPLE. THEREFORE, HETEROPHILE INTERFERENCE IS THE ROOT CAUSE FOR THIS PATIENT'S ELEVATED TROPONIN RESULTS. PRODUCT LABELING: FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES, E.G. HUMAN ANTI-MOUSE ANTIBODIES (HAMA), THAT INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE ANTIBODIES. 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 POINT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN 01/01/2008 THROUGH 10/23/2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN (ACCUTNI) PATIENT RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER TESTED A SAMPLE AND A NEGATIVE TROPONIN RESULT WAS OBTAINED VIA AN ALTERNATE METHODOLOGY. THE ELEVATED RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SENT PATIENT SAMPLES TO BECKMAN COULTER, INC. FOR HETEROPHILE 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 37 YR ACCESS ACCUTNI