BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172253 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01932
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    November 20, 2007
    Report Date
    November 21, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 SAMPLE WAS COLLECTED INTO A LITHIUM HEPARIN PLASMA TUBE WITH GEL. CENTRIFUGATION TIME AND SPEED WERE NOT SUPPLIED. QUALITY CONTROL (QC) AND SYSTEM CHECK DATA WERE NOT SUPPLIED BY THE CUSTOMER. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY TESTED THE PATIENT SAMPLE PROVIDED BY THE CUSTOMER AND CONFIRMED HETEROPHILE INTERFERENCE AS THE ROOT CAUSE OF THE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS. 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 PATIENTS 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 PATIENT SAMPLES. 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 (ACCUTNI) RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFORMATION. MEDICAL DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCUTNI DETERMINATION AT ONE TIME POINT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ELEVATED TROPONIN (ACCUTNI) PATIENT RESULT INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE PATIENT SAMPLE WAS RE-TESTED ON AN ALTERNATE METHODOLOGY AND PRODUCED A NEGATIVE RESULT. THE TWO TROPONIN RESULTS WERE DISCORDANT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE CUSTOMER CONFIRMED HETEROPHILE INTERFERENCE AFTER FURTHER SAMPLE TESTING. THERE WAS NO REPORT OF PATIENT INJURY. IT IS UNKNOWN IF CHANGE IN PATIENT TREATMENT IS ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. WITH THE PATIENT 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 79 YR ACCESS ACCUTNI