BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172114 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01772
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    October 4, 2007
    Report Date
    October 5, 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

    THE CUSTOMER DID NOT REQUEST SERVICE DUE TO SUSPECTING HETEROPHILE INTERFERENCE FOR THE PT. THE CUSTOMER COLLECTED PLASMA SAMPLES IN 13X100 PLASTIC LITHIUM HEPARIN TUBES WITH GEL. CENTRIFUGATION WAS PERFORMED AT 3000 ROTATIONS PER MINUTE (RPM) FOR 10 MINUTES AT ROOM TEMPERATURE IN A SWINGING BUCKET CENTRIFUGE. SPECIMENS WERE ROUTINELY SAMPLED FROM THE PRIMARY TUBES. THE CUSTOMER ALLOWED THE SAMPLES TO CLOT FOR 15-20 MINUTES, AND THE TUBES WERE INVERTED ACCORDING TO THE MFR'S RECOMMENDATIONS. THE CUSTOMER DOCUMENTED THE LAB USES SMALL FILTERS IN ALL LITHIUM HEPARIN TUBES TROPONIN TESTING. QUALITY CONTROL (QC) WAS WITHIN SPECS PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(4) 2007, WAS WITHIN SPECS. THERE WERE NO FLAGS OR ERROR CODES PRESENT. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB TESTED THE PT SAMPLE AND OBTAINED NEAT TROPONIN VALUE OF 0.65 NG/ML (SERUM) AND 0.62 NG/ML (PLASMA). DILUTION STUDIES INDICATE NON-LINEAR RECOVERY, AND CONFIRMED "HETEROPHILE INTERFERENCE" IN THE PT'S SAMPLE. THEREFORE, IT IS CONCLUSIVE THAT HETEROPHILE INTERFERENCE IS THE ROOT CAUSE FOR THE DISCORDANT RESULTS. 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 ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ELEVATED TROPONIN (ACCUTNI) PT RESULT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE PT WAS TESTED AT ANOTHER FACILITY AND A NEGATIVE TROPONIN RESULT WAS OBTAINED VIA AN UNK ALTERNATE METHODOLOGY. THERE WAS NO REPORT OF PT INJURY. A CHANGE IN PT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THE CUSTOMER SENT THE PT SAMPLE 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 39 YR ACCESS ACCUTNI