BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2142148 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01441
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    September 2, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE PERFORMED SYSTEM CHECK, HIGH SENSITIVITY (HS) SYSTEM CHECK, AND LOW LEVEL QC PRECISION TESTING. ALL TESTING WAS WITHIN PRODUCT SPECIFICATION. NO DEFINITIVE ROOT CAUSE CAN 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 ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) ON (B)(6) 2008 REGARDING ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE PATIENT. RESULTS WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. IT'S UNKNOWN IF THE INITIAL ACCUTNI RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENT 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