BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172098 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01776
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    October 17, 2007
    Report Date
    October 17, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE EVENT WAS ISOLATED TO A SPECIFIC PT SAMPLE. THE SAMPLE WAS COLLECTED IN A PLASTIC LIHEP TUBE WITH GEL SEPARATOR. THE SAMPLE WAS CENTRIFUGED AT 3200 RPM (ROTATIONS PER MINUTE) FOR 10 MINUTES. AN ETHYLENEDIAMINETETRAACETIC ACID (EDTA) SAMPLE FROM THIS PT RESULTED <0.05 ON A BIOSITE TRIAGE METHOD. SYSTEM CHECK WAS PERFORMED ON (B)(4) 2007 AND PASSED SPECS. QUALITY CONTROL (QC) INFO WAS NOT SUPPLIED. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB TESTED THE PT SAMPLE AND OBTAINED NEAT TROPONIN VALUE OF 7.02 NG/ML (SERUM) AND 5.93 NG/ML (PLASMA). DILUTION STUDIES INDICATE NON-LINEAR RECOVERY AND CONFIRMED "HETEROPHILE INTERFERENCE" IN THE PT'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 PTS 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 PT SAMPLES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN JANUARY 01, 2008 THROUGH OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERRONEOUS TROPONIN (ACCUTNI) PT RESULT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE PT'S SAMPLE PRODUCED 6.81 NG/ML AND 6.63 NG/ML FOR TROPONIN. THE RESULT WAS QUESTIONED AS CREATINE KINASE-MB (CK-MB) WAS WITHIN THE NORMAL REFERENCE. TESTING OF ANOTHER SAMPLE FROM THE SAME PT ON AN ALTERNATE METHODOLOGY, PRODUCED <0.05 NG/ML. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB. THERE WAS NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. TWO SAMPLES FROM THE PT WERE SENT TO BECKMAN COULTER, INC. FOR HETEROPHILE ANALYSIS.

    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 ACCESS ACCUTNI