BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172104 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01770
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    September 17, 2007
    Report Date
    September 18, 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

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE EVENT WAS ISOLATED TO A SPECIFIC PT SAMPLE. SAMPLE WAS COLLECTED INTO BD LITHIUM HEPARIN PLASMA WITH GEL TUBE. QUALITY CONTROL (QC) AND SYSTEM CHECK DATA WERE NOT SUPPLIED BY THE CUSTOMER. SAMPLES FROM THE PT IN QUESTION WAS SUPPLIED TO BECKMAN COULTER, INC., FOR ADD'L TESTING. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY TESTED THE SAMPLES WITH A MIXTURE OF INTERFERENCE-ELIMINATING PROTEINS. CPLS LABORATORY WAS ABLE TO REPLICATE THE ELEVATED RESULTS. BASED ON THIS INFO, IT IS CONCLUSIVE THAT THIS PT DID HAVE CIRCULATING HETEROPHILE ANTIBODIES CAUSING INTERFERENCE WITH THE TROPONIN (ACCUTNI) RESULTS. HETEROPHILE INTERFERENCE IS THE ROOT CAUSE FOR THE DISCORDANT RESULTS. PRODUCT LABELING: FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PT SAMPLE. PTS 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), THAT INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PTS SUSPECTED OF HAVING THESE ANTIBODIES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 THROUGH (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN (ACCUTNI) RESULTS FOR ONE PT INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE SAMPLE PRODUCED ON THE DXI 800 SYSTEM AT VALUES OF 2.8, 2.9, AND 2.59 NG/ML. THE SAMPLE WAS TREATED WITH SCANTABODIES HETEROPHILIC BLOCKING REAGENT (HBR) TUBES AND THE VALUE SIGNIFICANTLY REDUCED TO 0.52 NG/ML. TROPIN-I WERE TESTED TWO ADDITIONAL TIMES VIA AN ALTERNATE METHODOLOGY, RESULTS WERE NEGATIVE. IT IS UNK IF THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PT INJURY OR CHANGE IN PT 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 21 YR ACCESS ACCUTNI