BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2243985 · Received August 19, 2011

    Report

    Report Number
    2122870-2011-02961
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Report Date
    August 27, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SVC WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYS PERFORMANCE. UPON EXAMINATION BY A CARDIOLOGIST, THE PT RECEIVED AN ELECTROCARDIOGRAM (ECG). NO CLINICAL ISSUES WERE FOUND. NO ISCHEMIA WAS NOTED. THE PT SAMPLE WAS COLLECTED IN BD 13 X 75 MM LITHIUM HEPARIN PLASMA TUBES. CENTRIFUGATION WAS PERFORMED AT 3,000 RELATIVE CENTRIFUGAL FORCE (RCF) FOR 10 MINUTES AT 18 CELSIUS. THE SAMPLE WAS STORED AT 20 - 25 CELSIUS. QC (QC) WAS WITHIN SPEC PRIOR TO THE EVENT. INTERFERENCE TESTING WAS PERFORMED AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB AND REVEALED TWO KINDS OF INTERFERENCES: A HETEROPHILE INTERFERENCE AND AN INTERFERENCE WHICH LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND, DISTINCT FROM HETEROPHILE ANTIBODIES, CAUSSE REPRODUCIBLE FALSE POSITIVE 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. THE ACCESS 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 ADD'L TESTS, AND OTHER APPROPRIATE INFO. MEDICAL DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCUTNI DETERMINATION AT ONE TIME POINT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED FROM (B)(6) 2008 THROUGH (B)(6) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE AFFILIATE ALLEGED THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF, FOR ONE PT ON MULTIPLE SAMPLES INVOLVING ACCESS 2 IMMUNOASSAY SYS. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LAB, AND THE PHYSICIAN SUSPECTED HETEROPHILE INTERFERENCE. THE PT WAS EXAMINED BY CARDIOLOGISTS AND NO MEDICAL TREATMENT WAS INDICATED. THERE WAS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC IN EUROPE WITH THE PT SAMPLES FOR FURTHER 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 17 YR ACCESS ACCUTNI