BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2252951 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03704
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    January 7, 2009
    Report Date
    January 9, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE TO INVESTIGATE THE EVENT. THE FSE CLEANED THE TRACK, WASH WHEEL, REPLACED ASPIRATE PROBE TUBING, ASPIRATE PROBES, PINCH ROLLERS, PULLEY AND MIXER BELT. ALSO, THE FSE VERIFIED ALL ALIGNMENTS AND NO ERRORS WERE FOUND. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS IS 2 OF 21 SEPARATE MDR REPORTS RELATED TO 21 PTS EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS: MDR 2122870-2011-03703, MDR 2122870-2011-03704, MDR 2122870-2011-03705, MDR 2122870-2011-03706, MDR 2122870-2011-03707, MDR 2122870-2011-03708, MDR 2122870-2011-03709, MDR 2122870-2011-03710, MDR 2122870-2011-03711, MDR 2122870-2011-03712, MDR 2122870-2011-03713, MDR 2122870-2011-03714, MDR 2122870-2011-03715, MDR 2122870-2011-03716, MDR 2122870-2011-03717, MDR 2122870-2011-03718, MDR 2122870-2011-03719, MDR 2122870-2011-03720, MDR 2122870-2011-03721, MDR 2122870-2011-03722, MDR 2122870-2011-03723 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 THROUGH OCTOBER 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 TWENTY ONE PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PT SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER ONLY PROVIDED DATA FOR TWO PTS. 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI