BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMONOASSAY SYSTEM

    MDR report key: 2188504 · Received July 29, 2011

    Report

    Report Number
    2122870-2011-02595
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    August 2, 2008
    Report Date
    August 2, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    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

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE CUSTOMER HAS THERE OWN BIO MEDICAL DEPT THAT SERVICES THEIR INSTRUMENT. THE CUSTOMER'S BIO MEDICAL DEPT INSPECTED THE INSTRUMENT AND CLEANED THE ANALYTICAL UNIT OF SPILLED DRIED BUFFER, REPLACED A PINCH ROLLER AND THE INCUBATOR BELT AND REBUILT THE PRECISION. HARDWARE IS THE ROOT CAUSE OF THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 THROUGH (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE INITIAL ELEVATED RESULT WAS REPORTED OUTSIDE THE LAB. THE PT SAMPLE WAS RETESTED AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE CORRECTED RESULT WAS SENT OUT OF THE LAB. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMONOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR ACCESS ACCUTNI