BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172530 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-02005
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    April 16, 2008
    Report Date
    April 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO INVESTIGATE THE EVENT. THE FSE PERFORMED LUMWASH SON/INC, QC, AND PRECISION TESTING USING AN ACCUTNI LOW QC LEVEL. THE LUMWASH SON/INC. AND PRECISION TESTING RESULTS WERE WITHIN SPECIFICATION. THE FSE ALSO NOTED A LAYER OF RED CELLS IN THE PT SAMPLES IN QUESTION. THE CUSTOMER DID VERIFY THE SAMPLES CAME FROM ANOTHER LABORATORY THAT USES A POWER PROCESSOR. FURTHER INVESTIGATION CONDUCTED BY THE FSE AT THE OTHER LAB ALSO REVEALED RED CELL LAYERS IN THEIR SPECIMENS. THE FSE CHECKED THE SETTING OF THE CENTRIFUGE USED TO PROCESS THE SPECIMENS AND FOUND THE CENTRIFUGE IS NOT SET AT THE RECOMMENDED SPEED AND TIME AS PER THE BD RECOMMENDATIONS. THE FSE ADVISED THE CUSTOMER TO SET THE CENTRIFUGE TO THE SETTINGS OF BD. ALSO, NOTED BY THE FSE IS THAT THE CUSTOMER TYPICALLY FILTERS SPECIMENS AFTER CENTRIFUGATION AND PUTS SAMPLE INTO INSERT CUPS FOR ANALYSIS. THE FSE FOUND RED CELLS IN THE BOTTOM OF THE INSERT CUPS. PRE-ANALYTICAL SAMPLE HANDLING ISSUES IS THE ROOT CAUSE OF THIS EVENT. THIS IS TWO OF FOUR SEPARATE MDR REPORTS RELATED TO FOUR PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS 2122870-2011-02004, 02006, 02007 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 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 FOUR 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 ACCESS ACCUTNI