BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2161050 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02338
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    September 27, 2007
    Report Date
    October 10, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    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 EVENT WAS ISOLATED TO A SPECIFIC PATIENT SAMPLE. THE SAMPLES WERE COLLECTED IN LITHIUM HEPARIN TUBES WITH GEL AND SPUN AT 3600 RPM (ROTATIONS PER MINUTE) FOR 10 MINUTES AT ROOM TEMPERATURE. SYSTEM CHECK AND QUALITY CONTROL (QC) DATA PROVIDED WAS WITHIN SPECIFICATION. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY RECEIVED TWO PLASMA SAMPLES FROM THE SAME PATIENT FOR INVESTIGATION. HETEROPHILE TESTING CONFIRMED INTERFERING SUBSTANCES IN THE PATIENT BLOOD. IT IS CONCLUSIVE THAT THE CUSTOMER'S RESULTS WERE FALSELY ELEVATED BECAUSE OF HETEROPHILE INTERFERENCE. PRODUCT LABELING: FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS 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), THE INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS 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 (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 BETWEEN 01/01/2008 THROUGH 10/23/2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN (ACCUTNI) PATIENT RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF INVOLVING UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE PATIENT'S CREATINE KINASE-MB (CK-MB) WAS WITHIN NORMAL RANGE. THE CUSTOMER STATED ANOTHER PATIENT SAMPLE WAS DRAWN SEVERAL HOURS AFTER WITH AN ELEVATED TROPONIN RESULT. THE PATIENT WAS SENT TO THE CARDIAC CATHETER LABORATORY AND TROPONIN RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER STATED, THE PATIENT HAS BEEN SEEN BY A CARDIOLOGIST WITH REGULAR TROPONIN TESTING, AND THE RESULTS WERE ELEVATED. THE CUSTOMER SUSPECTED HETEROPHILIC INTERFERENCE AND SENT PATIENT SAMPLE TO BECKMAN COULTER, INC. FOR HETEROPHILE ANALYSIS. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT INJURY. A CHANGE IN PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR ACCESS ACCUTNI