BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2230603 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02811
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 20, 2008
    Report Date
    July 28, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE PLASMA SAMPLES WERE COLLECTED IN LITHIUM HEPARIN TUBES. TROPONIN I QUALITY CONTROL (QC) LEVEL ONE RESULTED WITHIN SPECIFICATIONS ON THE DAYS THE PT SAMPLES WERE PROCESSED. TROPONIN I QC LEVEL THREE RESULTED OUT OF SPECIFICATIONS (LOW) ON (B)(6) 2008. QC LEVEL THREE VALUES ON OTHER DAYS OF TESTING RESULTED WITHIN SPECIFICATIONS. A SYSTEM CHECK PERFORMED ON (B)(6) 2008 CONFORMED TO SPECIFICATIONS. INTERFERENCE TESTING WAS PERFORMED BY BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY AND CONFIRMED HETEROPHILE INTERFERENCE WHICH LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND DISTINCT FROM HETEROPHILE ANTIBODIES CAUSES REPRODUCIBLE FALSE POSITIVE RESULTS. 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 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. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2011-02812.

    Description of Event or Problem · 1

    THE AFFILIATE ALLEGED THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF, FOR ONE PT ON SEVERAL SAMPLES INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THIS REPORT NUMBER ONE OF TWO REFERENCING SYSTEM SERIAL NUMBER (B)(4). THE ELEVATED RESULTS WERE DISCORDANT TO TWO ALTERNATE METHODOLOGIES, WHICH WERE NEGATIVE. THE ELEVATED RESULTS DID NOT CORRELATE WITH THE PT'S CLINICAL CONDITION. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE PT REC'D CORONAROGRAPHY WITH NO DIAGNOSTIC DETECTION. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. IN (B)(4) WITH THE PT SAMPLES FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other ACCESS ACCUTNI