BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2211662 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02626
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. TESTING AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY CONFIRMED AN INTERFERENCE SUBSTANCE WHICH LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND, DISTINCT FROM HETEROPHILE ANTIBODIES, CAUSES REPRODUCIBLE FALSE POSITIVE RESULTS. 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. 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 ADDITIONAL 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 PRODUCT COMPLAINTS CONDUCTED FROM (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE AFFILIATE ALLEGED THE CUSTOMER REPORTED ELEVATED TROPONIN T (ACCUTNI) RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF, FOR ONE PT INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ELEVATED RESULT WAS DISCORDANT TO TWO ALTERNATE METHODOLOGIES, WHICH WERE NEGATIVE. THE ELEVATED RESULT WAS NOT RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. IN (B)(4) WITH THE PT SAMPLE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR ACCESS ACCUTNI| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM