BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172255 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01947
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    November 23, 2007
    Report Date
    November 23, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD APPLICATION SUPPORT (FAC) WAS DISPATCHED AND PERFORMED FIELD DIAGNOSTIC TESTING SUCCESSFULLY. THE UNIT CONFORMED TO SPECIFICATIONS. THE PATIENT HAD NORMAL CREATINE KINASE-MB (CK-MB), MYOGLOBIN AND ELECTROCARDIOGRAM (ECG) RESULTS. SAMPLES WERE COLLECTED IN BD SERUM AND ETHYLENEDIAMINETETRAACETIC ACID (EDTA) TUBES WITH GEL AND SPUN AT 1800G FOR 10 MINUTES. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION PRIOR TO THE EVENT. SYSTEM CHECK CONFORMED TO SPECIFICATION. PATIENT SAMPLES WERE SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY - FRANCE, FOR HETEROPHILE ANALYSIS. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. 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. 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 AFFILIATE ALLEGED THE CUSTOMER REPORTED ELEVATED TROPONIN-I (ACCUTNI) RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF FROM ONE PATIENT INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULTS WERE DISCORDANT TO AN ALTERNATE METHODOLOGY WHICH WAS NEGATIVE. THE CUSTOMER SUSPECTED HUMAN ANTI-MOUSE ANTIBODIES (HAMA) INTERFERENCE AND REQUESTED BECKMAN COULTER, FRANCE TO PERFORM FURTHER ANALYSIS ON THE PATIENT SAMPLE. THE ELEVATED RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    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 UNK ACCESS ACCUTNI