BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2184108 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-02143
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Report Date
    February 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. SAMPLE AND CENTRIFUGE INFORMATION WERE NOT SUPPLIED. APPLICATIONS PERSONNEL PERFORMED A LINEAR DILUTION AND THE SAMPLE DID NOT DILUTE LINEARLY. THE SAMPLE WAS TESTED USING DADE DIMENSION AND PRODUCED A RESULT OF 0.00 UG/L FOR TROPONIN. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS. SYSTEM CHECK INFORMATION WAS NOT SUPPLIED BY THE CUSTOMER. (B)(6) DOES NOT ALLOW BIOLOGICAL SAMPLES TO LEAVE THE COUNTRY, THUS FURTHER PATIENT SAMPLE ANALYSIS BY BECKMAN COULTER, INC COULD NOT BE COMPLETED. THE ROOT CAUSE OF THE ELEVATED TROPONIN I RESULTS IS UNDETERMINED. 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 PATIENTS 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 PATIENT SAMPLES. IN ADDITION, ELEVATED TROPONIN I LEVELS HAVE ALSO BEEN DOCUMENTED IN CASES IN OTHER CARDIAC CONDITIONS SUCH AS UNSTABLE ANGINA, CONGESTIVE HEART FAILURE, OR MYOCARDITIS, OR SEVERE NON-CARDIAC CONDITIONS SUCH AS TRAUMA OR RENAL FAILURE THAT MAY CAUSE CARDIAC MUSCLE INJURY. THUS TROPONIN I (ACCUTNI) RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFORMATION. MEDICAL DECISIONS SHOULD NOT BE CASED ON A SINGLE ACCUTNI DETERMINATION AT ONE TIME POINT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2011-02116.

    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 PATIENT'S SAMPLE INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THIS IS REPORT NUMBER 2 OF 2. THE ELEVATED RESULTS DID NOT CORRELATE WITH CLINICAL PRESENTATION AND WERE DISCORDANT TO AN ALTERNATE METHODOLOGY, WHICH WAS NEGATIVE. THE ELEVATED RESULTS WERE RELEASED AND QUESTIONED BY THE PHYSICIAN. THERE HAS BEEN NO REPORT OF PATIENT INJURY. A CHANGE IN PATIENT TREATMENT WAS NOTED. THE CUSTOMER DID NOT SUPPLY BECKMAN COULTER, INC WITH THE PATIENT SAMPLE 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 UNK ACCESS ACCUTNI