BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2142146 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01439
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    March 14, 2008
    Report Date
    March 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. FSE VERIFIED INSTRUMENT PER TYPE 1 VERIFICATION PROTOCOL AND NO HARDWARE ISSUES WERE IDENTIFIED. THE SYSTEM CHECK DATA THAT WAS PERFORMED ON (B)(6) 2008, WAS REVIEWED AND IT WAS WITHIN SPECIFICATION. NO DEFINITIVE CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMANN COULTER INC, (BCI) ON (B)(6) 2008 REGARDING ACCUTNI (TROPONIN) RESULT THAT WAS WITHIN THE RISK STRATIFICATION RANGE FOR ONE PT. RESULTS WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER RE-RAN THE SAMPLE ON A DIFFERENT INSTRUMENT AND THE RESULT WAS WITHIN THE NORMAL RANGE. THE INITIAL ELEVATED ACCUTNI RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI