BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 SYSTEM

    MDR report key: 2171178 · Received July 1, 2011

    Report

    Report Number
    2050012-2011-02607
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    January 21, 2008
    Report Date
    January 23, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT REQUESTED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE CUSTOMER COLLECTED SAMPLES IN PLASTIC BD LITHIUM HEPARIN TUBES. CENTRIFUGATION OF SAMPLES WAS PERFORMED FOR MORE THAN FIVE MINUTES AT ROOM TEMPERATURE. ROTATIONS PER MINUTE (RPM) DATA WAS NOT SUPPLIED BY THE CUSTOMER. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS. SYSTEM CHECK PERFORMED ON (B)(4) 2008 CONFORMED TO SPECIFICATIONS. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB TESTING CONFIRMED HETEROPHILIC INTERFERENCE AS THE ROOT CAUSE FOR THE PT'S ELEVATED TROPONIN I (ACCUTNI) 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. 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 I (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 ADD'L REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDR 2050012-2011-02610.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ELEVATED TROPONIN I (ACCUTNI) PT RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) FROM ONE PT INVOLVING SYNCHRON LXI 725 SYSTEM. THIS IS REPORT NUMBER ONE OF TWO. THE RESULTS WERE DISCORDANT TO AN UNK ALTERNATE METHODOLOGY, WHICH PRODUCED A RESULT OF <0.01 NG/ML. THE ELEVATED RESULTS WERE REPORTED OUT OF THE LAB AND QUESTIONED BY PHYSICIANS. THE CUSTOMER INFORMED THE PHYSICIAN ON HETEROPHILE INTERFERENCE WITH IMMUNOASSAY TESTING. THE CUSTOMER STATED THE PT WAS SENT TO THE CATHETERIZATION LAB. THERE WAS NO REPORT OF PT INJURY. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC WITH THE PT SAMPLES FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI 725 SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR ACCESS ACCUTNI