BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2231091 · Received August 26, 2011

    Report

    Report Number
    2122870-2011-03021
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    September 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE CUSTOMER COLLECTED SAMPLES IN PLASTIC BD LITHIUM HEPARIN TUBES WITH GEL. SAMPLES WERE CENTRIFUGED AT GREATER THAN 5,000 RPM (ROTATIONS PER MINUTE) FOR OVER 5 MINUTES. SYSTEM CHECKS PERFORMED ON (B)(6) 2008 CONFORMED TO SPECIFICATIONS. TESTING AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY CONFIRMED THE EXISTENCE OF A PT SOURCE INTERFERENT FOR THE PT'S SAMPLE RECEIVED FROM THE CUSTOMER. THE INTERFERENCE LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND CAUSES REPRODUCIBLE 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. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2011-03020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONSISTENTLY ELEVATED TROPONIN I (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF, FOR ONE PT ON TWO SAMPLES INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THIS REPORT NUMBER TWO OF TWO REFERENCING SYSTEM SERIAL NUMBER (B)(4). THE CUSTOMER STATED ONE SAMPLE PRODUCED A RESULT OF 115 MG/DL. THE CUSTOMER PERFORMED HETEROPHILE BLOCKING TUBE TESTING AND PRODUCED A RESULT OF 0.40 NG/ML FROM PREVIOUS ELEVATED RESULT OF 141 NG/ML. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE PT UNDERWENT A HEART CATHETERIZATION PROCEDURE AND REVEALED NO ABNORMALITIES. THE PHYSICIAN SUSPECTED HETEROPHILE INTERFERENCE AND SUPPLIED BECKMAN COULTER, INC. WITH THE PT SAMPLES 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 55 YR Required Intervention ACCESS ACCUTNI