BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2258863 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03351
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    December 23, 2008
    Report Date
    December 23, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DECLINED BCI SERVICE, STATING THAT THEIR BIO-MED WOULD PERFORM MAINTENANCE. A BCI FIELD SERVICE ENGINEER (FSE) DID NOT EVALUATE THE SYSTEM. THE CUSTOMER'S BIO-MED ENGINEER PERFORMED PREVENTATIVE MAINTENANCE ON THE INSTRUMENT, BUT CUSTOMER COULD NOT IDENTIFY ANY HARDWARE ISSUES. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS IS 2 OF 2 SEPARATE MDR REPORTS RELATED TO 2 PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS 212870-2011-03350, 2122870-2011-03351 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 THROUGH OCTOBER 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) RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PTS. THE PT SAMPLES WERE RETESTED AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ELEVATED 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI