BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCES IMMUNOASSAY SYSTEM

    MDR report key: 2263832 · Received September 16, 2011

    Report

    Report Number
    2122870-2011-03727
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    July 27, 2009
    Report Date
    August 7, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE ERRONEOUS RESULT. NO DATA WAS SUPPLIED. THE CUSTOMER TREATED THE PATIENT'S SAMPLE FROM THE TWENTY-NINTH WITH SCANTIBODY BLOCKERS. ACCU TNI TEST RESULTS WAS 0.031NG/ML. THIS REDUCTION IN CONCENTRATION AFTER THE ADDITION OF BLOCKERS IS INDICATIVE OF HETEROPHILE INTERFERENCE. THE PHYSICIAN WAS SATISFIED WITH THIS INFORMATION AND THE CUSTOMER DID NOT FIND IT NECESSARY TO SEND THE SAMPLE TO BECKMAN COULTER INC FOR FURTHER TESTING. SERVICE WAS NOT DISPATCHED. SINCE THE SAMPLE WAS NOT SENT TO BECKMAN COULTER INC TO CONFIRM THE PRESENCE OF HETEROPHILE ANTIBODIES, ROOT CAUSE WAS NOT DEFINITIVELY IDENTIFIED. HOWEVER, THE PRESENCE OF HETEROPHILE ANTIBODIES, AS DEMONSTRATED BY THE CUSTOMER, IS MOST LIKELY THE CAUSE OF THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH ACCU TNI (TROPONIN I) TEST RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE WHEN USING THE UNICEL DXI 800 ACCESS IMMUNOASSAYS SYSTEM. THE ERRONEOUS HIGH TEST RESULTS WERE ABOVE THE NORMAL REFERENCE RANGE, AND BELOW THE AMI (ACUTE MYOCARDIAL INFARCTION) CUTOFF OF 0.50 NG/ML. TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. REPEAT ANALYSIS WAS PERFORMED USING A CENTAUR. THE TEST RESULTS WERE WITHIN THE NORMAL RANGE. THE CUSTOMER DETECTED THE PRESENCE OF HETEROPHILE ANTIBODIES IN THE SAMPLE FROM (B)(4) 2009. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCES IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCU TNI