BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172514 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-02012
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 5, 2008
    Report Date
    May 5, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE INSPECTED THE INSTRUMENT AND FOUND THE MIXER MOTOR TIMING PULLEY WAS STICKING INTERMITTENTLY WHICH CAUSED THE REVOLUTIONS PER MINUTES (RPM) TO BE REDUCED CLOCK AND COUNTER CLOCK WISE. THE FSE REPLACED THE 10T AND 14T MIXER ASSEMBLY AND MIXER BELT. THE FSE RAN A SYSTEM CHECK AND CARDIAC QUALITY CONTROLS (QCS) BOTH RESULTS WERE WITHIN SPECIFICATION. THE FSE VERIFIED THE INSTRUMENT PER ESTABLISHED PROCEDURES AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT. 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 ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) AND ELEVATED CK-MB RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE PT SAMPLE WAS RETESTED ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL RESULTS WERE NOT 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 UNK ACCESS CK-MB| ACCESS ACCUTNI