BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2147114 · Received June 10, 2011

    Report

    Report Number
    2122870-2011-01747
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    September 14, 2007
    Report Date
    September 17, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR INSTRUMENT VERIFICATION AS THE EVENT WAS ISOLATED TO A SPECIFIC PT SAMPLE. THE SAMPLE TYPE WAS PLASMA. THE NUMBER OF INVERSIONS AT TIME OF COLLECTION WAS NOT SUPPLIED. CENTRIFUGATION OCCURRED AT 3500 RPM (ROTATIONS PER MINUTE) FOR 10 MINUTES AT ROOM TEMPERATURE. THE SAMPLE WAS TESTED WITHIN 30 MINUTES FOLLOWING INITIAL COLLECTION AND WAS STORED REFRIGERATED. QUALITY CONTROL (QC) PERFORMED PRIOR TO AND FOLLOWING THE EVENT RESULTED IN RANGE. SYSTEM CHECK DATA WAS NOT SUPPLIED. NO FLAGS OR ERROR CODES WERE ASSOCIATED WITH THE EVENT. A SAMPLE FROM THE PT IN QUESTION WAS SUPPLIED TO BECKMAN COULTER, INC. FOR ADDITIONAL TESTING. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY TESTED THE SAMPLE NEAT AND REPRODUCED THE ELEVATED VALUES. FURTHERMORE, THE ADDITION OF HETEROPHILE BLOCKING AGENTS SIGNIFICANTLY REDUCED THE TROPONIN CONCENTRATION TO THE RISK STRATIFICATION RANGE. BASED ON THIS INFO, IT IS CONCLUSIVE THAT THIS PT DID NOT HAVE CIRCULATING HETEROPHILE ANTIBODIES CAUSING INTERFERENCE WITH THE TROPONIN (ACCUTNI) RESULTS. HETEROPHILE INTERFERENCE IS THE ROOT CAUSE OF THE EVENT. PRODUCT LABELING: FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PT SAMPLE. PTS 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 PT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PTS SUSPECTED OF HAVING THESE ANTIBODIES. 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 MDRS: 2122870-2011-01748 AND 2122870-2011-01749.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ELEVATED TROPONIN (ACCUTNI) RESULT FOR ONE PT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THIS IS REPORT NUMBER ONE OF THREE. THE SAMPLE PRODUCED A NEGATIVE RESULT VIA AN ALTERNATE METHODOLOGY. QUALITY CONTROL (QC) PERFORMANCE WAS ACCEPTABLE, AND THE ISSUE WAS ISOLATED TO THIS SPECIFIC PT. THE PHYSICIAN AGREED WITH THE RESULT FROM THE ALTERNATE METHOD BASED ON OTHER DIAGNOSTIC CRITERIA. THE CUSTOMER STATED CREATINE KINASE-MB (CK-MB) RESULTS WERE NORMAL, AT APPROX 1.63 NG/ML. THE ELEVATED VALUES WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT 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