BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2356166 · Received December 1, 2011

    Report

    Report Number
    2122870-2011-05759
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Date of Event
    January 16, 2009
    Report Date
    January 19, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2009, TO INVESTIGATE THE EVENT. THE FSE INSPECTED THE INSTRUMENT HARDWARE AND VERIFIED NO LEAKS IN SYSTEM. THE FSE ALSO PERFORMED HSLUMWASH SON/INC AND IT HAS PASSING RESULTS. THE FSE THEN PERFORMED A 20-REPETITION PRECISION RUN OF ACCUTNI. THE PRECISION RUN YIELDED PASSING RESULTS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 01/01/2008 THROUGH 10/23/2010 FOR ADDITIONAL 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 FOR ONE PT. THE PT SAMPLES WERE RETESTED AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. A CORRECTED REPORT WAS SENT OUTSIDE THE LABORATORY. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. 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 IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR ACCESS ACCUTNI