BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2171140 · Received July 1, 2011

    Report

    Report Number
    2122870-2011-02039
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    December 10, 2007
    Report Date
    December 13, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THE UNIT WAS PERFORMING WELL AND DID NOT REQUEST SERVICE. THE SAMPLE WAS OBTAINED BY A NURSE FROM THE PT'S PICK LINE. CREATINE KINASE-MB (CK-MB) WAS WITHIN THE NORMAL RANGE, RESULTS WERE NOT PROVIDED. SYSTEM INFO WAS NOT SUPPLIED BY THE CUSTOMER. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB TESTED THE PT SAMPLE AND PRODUCED 22.1 NG/ML. ADDITIONAL TESTING REDUCED TROPONIN-I VALUE TO 0.054 NG/ML INDICATING HETEROPHILE INTERFERENCE IN THE PT SAMPLE. HETEROPHILE INTERFERENCE IS THE ROOT CAUSE OF THE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM JANUARY 01, 2008 THROUGH OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS. 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. 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 PT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFO. MEDICAL DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCUTNI DETERMINATION AT ONE TIME POINT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN-I (ACCUTNI) RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF FOR ONE PT'S SAMPLES INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE ELEVATED RESULTS DID NOT CORRELATE WITH THE PT'S CLINICAL CONDITION. THE CUSTOMER SUSPECTED SUBSTANCE INTERFERENCE. THE ELEVATED RESULTS WERE RELEASED AND QUESTIONED BY THE PHYSICIAN. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC WITH THE PT SAMPLE FOR FURTHER 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