BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172097 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01779
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    August 3, 2007
    Report Date
    September 21, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE EVENT WAS ISOLATED TO A SPECIFIC PT SAMPLE. THE CUSTOMER COLLECTED SAMPLES IN 5 ML HEPARIN TUBES WITH GEL. CENTRIFUGATION DATA WAS NOT SUPPLIED. THE CUSTOMER PROVIDED ONLY QUALITY CONTROL (QC) DATA FOR TROPONIN QC LEVEL ONE ON THE DATE OF THE EVENT, WHICH WAS WITHIN SPECS. THE CUSTOMER SENT SAMPLES FROM THE PT TO BECKMAN COULTER, INC. FOR ADDITIONAL TESTING. CUSTOMER PRODUCT LINE SUPPORT (CPLS) REPRODUCED THE CUSTOMER'S RESULTS. DILUTION TEST RESULTS DETECTED INTERFERENCE SINCE THE TEST WAS NOT LINEAR. HETEROPHILE TESTING LOWERED THE SIGNAL DEMONSTRATING THE PRESENCE OF INTERFERING SUBSTANCES. THEREFORE, IT IS CONCLUSIVE THAT THE PT'S RESULTS WERE FALSELY ELEVATED BECAUSE OF INTERFERING SUBSTANCES IN THE PT'S SAMPLES. 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 PTS 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 PT SAMPLES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010, FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE AFFILIATE ALLEGED THE CUSTOMER REPORTED ELEVATED TROPONIN (ACCUTNI) PT RESULTS FROM THREE DIFFERENT TUBES ON TWO DIFFERENT BLOOD DRAWS INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER QUESTIONED SUBSTANCE INTERFERENCE AND SENT THE PT'S SAMPLE TO ANOTHER HOSP WHERE A NEGATIVE TROPONIN RESULT WAS OBTAINED FROM AN ALTERNATE METHODOLOGY. IT IS UNK IF THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LAB. 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 46 YR ACCESS ACCUTNI