BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172535 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01945
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    April 13, 2008
    Report Date
    April 18, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE PERFORMED SYS CHECK AND RESULTS WERE WITHIN INSTRUMENT SPECS. THE FSE ALSO PERFORMED A LUM WASH SON/INC DIAGNOSTIC TESTING AND RESULTS WERE WITHIN SPECS. THE FSE VERIFIED ALL REPAIRS PER ESTABLISHED PROCEDURES AND THE RESULTS MEET PUBLISHED PERFORMANCE SPECS. 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 ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO FALSELY ELEVATED ACCUTNI (TROPONIN I) RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYS. THE INITIAL ELEVATED RESULTS WERE REPORTED OUTSIDE THE LAB. THE PT SAMPLES WERE RETESTED AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    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 UNK ACCESS ACCUTNI