BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172241 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01977
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    November 28, 2007
    Report Date
    November 28, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    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 ISSUE WAS NOT HARDWARE RELATED (SAMPLES WERE REPEATED WITHIN PRECISION CLAIMS ON THE DXI 800 UNIT). SAMPLE COLLECTION AND CENTRIFUGATION DATA WAS NOT SUPPLIED. PATIENT SAMPLES WERE SENT TO A THIRD FACILITY FOR TESTING ON DADE RXL INSTRUMENTATION AND NEGATIVE TROPONIN RESULTS WERE OBTAINED FROM BOTH SAMPLES. CUSTOMER TECHNICAL SUPPORT (CTS) DISCUSSED DILUTION TESTING IN RELATION TO HETEROPHILES AND HETEROPHILE BLOCKING TUBES WITH THE CUSTOMER. CTS OFFERED JOURNAL ARTICLES RELATED TO HETEROPHILES AND THE CUSTOMER DECLINED. THE CUSTOMER SENT AMENDED NEGATIVE TROPONIN REPORTS FOR THE PATIENT. THE CUSTOMER STATED DOCUMENTATION WOULD BE PLACED IN THE PATIENT'S FILE INDICATING INTERFERENCE WITH THE TROPONIN ASSAY FOR FUTURE REFERENCE. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS. BOTH SAMPLES TESTED BY CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY REPORTED A NEAT VALUE EQUAL TO WHAT THE CUSTOMER WAS RECEIVING. BOTH SAMPLES DID NOT DILUTE LINEARLY. SAMPLE # 2 WAS MODERATELY HEMOLYZED (APPROXIMATELY 300 MG/DL HEMOGLOBIN) AND CONTAINED SOME POSSIBLE CELLULAR MATTER. A REDUCTION IN SAMPLE #2'S SIGNAL WAS LIMITED DUE TO INTERFERENCE IN THE HEMOLYZED SAMPLE. NO SAMPLE REMAINED FOR FURTHER TESTING. 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. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(4), 2008 THROUGH (B)(4), 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 ON TWO SAMPLES FROM ONE PATIENT INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE PATIENT WAS BEING TREATED IN THE EMERGENCY ROOM (ER) PRIOR TO THIS EVENT. THE PATIENT WAS HELD FOR OBSERVATION ONLY. THE RESULTS WERE DISCORDANT TO ALTERNATE METHODOLOGIES WHICH WERE NEGATIVE. BECKMAN COULTER, INC. INFORMED THE CUSTOMER OF A POSSIBLE HETEROPHILE INTERFERENCE WITH THE PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. WITH THE PATIENT 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 27 YR ACCESS ACCUTNI