BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2231092 · Received August 26, 2011

    Report

    Report Number
    2122870-2011-03145
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    October 24, 2007
    Report Date
    October 7, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE SAMPLE CHOICE FOR TROPONIN I WAS RERUN COLLECTED IN GREINER GEL AND NON-GEL TUBES. THE CUSTOMER PERFORMED QUALITY CONTROL (QC) ON A DAILY BASIS WITH CALIBRATIONS AS NEEDED. TESTING AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY CONFIRMED THE EXISTENCE OF A PT SOURCE INTERFERENT FOR THE PT SAMPLE RECEIVED FROM THE CUSTOMER. THE INTERFERENCE LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND CAUSES REPRODUCTIBLE FALSE POSITIVE RESULTS, BUT IS DISTINCT FROM HETEROPHILE ANTIBODIES. 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 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)(6) 2008 THROUGH (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF, FOR ONE PT IN MULTIPLE SAMPLES INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ELEVATED RESULTS WERE DISCORDANT TO AN ALTERNATE METHODOLOGY, WHICH WAS NEGATIVE. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY. THE PT UNDERWENT CATHETERIZATION PROCEDURE AND WAS TREATED AS A PT WITH MYOCARDIAL INFARCTION (MI). IT WAS LATER DETERMINED THE PT DID NOT HAVE MYOCARDIAL INFARCTION. 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 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ACCESS ACCUTNI