BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2230602 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02746
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 2, 2008
    Report Date
    July 2, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE CUSTOMER STATED THE PT DID NOT HAVE MYOCARDIAL INFARCTION (MI). THE CUSTOMER STRONGLY SUSPECTED HETEROPHILE INTERFERENCE. THE SAMPLE WAS COLLECTED IN A BD LITHIUM HEPARIN PLASMA TUBE WITH A GEL SEPARATOR AND PROCESSED ON THE AUTOMATION LINE. 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 REC'D 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. THE ACCESS ACCUTNI RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADD'L TESTS, AND OTHER APPROPRIATE INFO. 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)(6) 2008 THROUGH (B)(6) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF, FOR ONE PT ON MULTIPLE SAMPLES INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ELEVATED RESULTS WERE REPRODUCIBLE AND DISCORDANT TO AN ALTERNATE METHODOLOGY, WHICH WAS NEGATIVE. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY. THE CUSTOMER STATED THE PT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND WAS DISCHARGED AFTER 23 HRS. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT HAVE PT SAMPLES TO SUPPLY BECKMAN COULTER, INC. 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 UNK Hospitalization ACCESS ACCUTNI