BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2152308 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01938
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    February 25, 2008
    Report Date
    February 25, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE (B)(4) 2008, TO INVESTIGATE THE EVENT. THE FSE WAS WORKING WITH SYSTEMS TECH SUPPORT IN REGARDS TO THE RETURN OF ULTRASONIC'S FAILURE ON LOWER ERRORS ON SERIAL (B)(4). THE FSE DID NOT INDICATE IF ANY REPAIRS WERE CONDUCTED. THE FSE PERFORMED THE LUM WASH DIAGNOSTIC TESTING ON BOTH SYSTEMS AND BOTH PASSED WITHIN SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT 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 ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) RESULT GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT SAMPLES WAS RETESTED ON A DIFFERENT INSTRUMENT AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE CORRECT RESULT WAS 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 87 YR ACCESS ACCUTNI