BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2161051 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01901
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    March 2, 2008
    Report Date
    March 2, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS NOT ALLOWED TO INVESTIGATE THE EVENT UNTIL (B)(4) 2008. THE FSE PERFORMED HIGH SENSITIVITY SYSTEM CHECK AND DIAGNOSTIC TESTING WHICH ALL PASSED ACCORDING TO INSTRUMENT SPECIFICATION. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ELEVATED ACCUTNI (TROPONIN I) RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT PATIENT DRAWS WERE TESTED AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ELEVATED RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR ACCESS ACCUTNI