BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2184168 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-02165
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    January 13, 2009
    Report Date
    January 13, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ONSITE ON (B)(4) 2009 TO INVESTIGATE THE EVENT. THE FSE PERFORMED A 20-POINT ACCUTNI PRECISION RUN THAT PASSED WITHIN SPECIFICATION. THE FSE ALSO PERFORMED A SYSTEM CHECK, AND A HIGH SENSITIVITY LUMWASH SON/INC WHICH PASSED ALL SPECIFICATIONS. THE FSE VERIFIED THE INSTRUMENT IS PERFORMING TO PUBLISHED SPECIFICATIONS. NO HARDWARE ISSUES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 01/01/2008 THROUGH 10/23/2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ELEVATED ACCUTNI (TROPONIN I) RESULT GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT SAMPLE WAS RETESTED ON ANOTHER INSTRUMENT AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ELEVATED RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT.

    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