BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2148887 · Received June 8, 2011

    Report

    Report Number
    2122870-2011-01673
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    July 12, 2007
    Report Date
    August 20, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE DETAILS WERE NOT SUPPLIED. CLINICAL HISTORY OF THE PATIENT WAS NOT SUPPLIED. QUALITY CONTROL (QC) DATA SUPPLIED INDICATES QC WAS NOT PERFORMED ON (B)(6)-2007 OR (B)(6)-2007. TWO LEVELS OF QC WERE PERFORMED ON (B)(6)-2007 AND WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGE. ONLY ONE LEVEL QC PERFORMED ON (B)(6)-2007 AND WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGE. SYSTEM CHECK DATA FROM (B)(6)-2010, (B)(6)-2010, (B)(6)-2010, AND (B)(6)-2010 WERE SUPPLIED AND ALL RESULTS MET SPECIFICATIONS. THE CUSTOMER PROVIDED ONE OF THE PATIENT'S SAMPLES TO BECKMAN COULTER, INC FOR FURTHER ANALYSIS. THE PATIENT SAMPLE WAS FIRST TESTED NEAT FOR TROPONIN (ATNI) TO REPEAT THE CUSTOMER'S RESULT. A SECOND DILUTION TEST WAS PERFORMED BY CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY. CPLS REPEATED THE CUSTOMER'S RESULTS. DILUTION TEST RESULTS ALLOWED DETECTION OF INTERFERENCE SINCE THE TEST WAS NOT LINEAR. FURTHERMORE, HETEROPHILE TESTING LOWERED THE SIGNAL DEMONSTRATING THE PRESENCE OF INTERFERING SUBSTANCES IN THE SAMPLE. IT IS CONCLUSIVE THAT THE CUSTOMER'S RESULTS ARE FALSELY ELEVATED BECAUSE OF INTERFERING SUBSTANCES IN THE PATIENT BLOOD. 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. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 TO (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS. RELATED MDRS: 2122870-2011-01666, 2122870-2011-01671, 2122870-2011-01672.

    Description of Event or Problem · 1

    THE AFFILIATE ALLEGED THE CUSTOMER REPORTED ELEVATED ERRONEOUS TROPONIN (ACCUTNI) PATIENT RESULTS ON FOUR SAMPLES INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THIS REPORT REFERS TO SAMPLE NUMBER FOUR. THE ACCUTNI RESULTS WERE BELOW THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF. THE PATIENT WAS SENT TO A SPECIALIZED CLINIC WHERE A NEW SAMPLE WAS ANALYZED ON ROCHE E170 AND BIOMERIEUX VIDAS SYSTEMS. THE RESULTS WERE NEGATIVE ON THE TWO ALTERNATE METHODS. THE SAMPLE WAS ALSO ANALYZED ON UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND PRODUCED 0.34 NG/ML. A LINEAR DILUTION WAS MADE AND PRODUCED 0.62 NG/ML, INDICATING INTERFERENCE. THE ELEVATED VALUES WERE REPORTED OUTSIDE THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR A CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCUTNI ON THE ACCESS IMMUNOASSAY SYSTEM| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM