BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2223231 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02863
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 24, 2008
    Report Date
    August 24, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 INVESTIGATING THE EVENT. THE FSE REVIEWED PT DATA AND QC DATA WITH CUSTOMER, AND CHECKED EVENT LOGS FOR ANY USUAL OCCURRENCES. NO UNUSUAL ERRORS WERE FOUND IN THE EVENT LOG. THE FSE COMPLETED THE UPPER PRECISION PUMP MOD. ALSO, THE FSE NOTED THE INSTRUMENT WAS DUE FOR PREVENTATIVE MAINTENANCE (PM). THE FSE COMPLETED THE PM AND A TNI PROTOCOL PROCEDURE ON PM TASK. THE FSE PERFORMED HIGH SENSITIVITY (HS) SYSTEM CHECK, WHICH PASSED. THEN THE FSE PERFORMED QUALITY CONTROL (QC) PRECISION TESTING, WHICH FAILED DUE TO ELEVATED CV OF 41% AT A MEAN DOSE CONCENTRATION OF 0.04 [MG/ML]. THE FSE REPLACED THE INCUBATOR BELT BEARINGS, "REACTION CAROUSEL BEARINGS," MAIN PIPETTOR, ADJUSTED AND VERIFIED ULTRASONICS. ALSO, THE FSE REPLACED THE DISPENSE PROBES AND VERIFIED DISPENSE VOLUMES. THE FSE REPEATED HS SYSTEM CHECK, WHICH PASSED AND COMPLETED A 50 REPLICATE PRECISION TEST WITH LOW QC, AND THE RESULTS MET IMPRECISION EXPECTATIONS. THE FSE RAN SYSTEM CHECK AND QC, ALL RESULTS WERE IN SPECIFICATION. ALL REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATION. ALTHOUGH THE FSE ADDRESSED HARDWARE ISSUES, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS IS 2 OF 5 SEPARATE MDR REPORTS RELATED TO 5 PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS: 2122870-2011-02862, 02864, 02865, 02666 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JAN 1, 2008 THROUGH OCT 23, 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ELEVATED ACCUTNI (TROPONIN I) RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR FIVE PTS. THE INITIAL ELEVATED RESULTS WERE NOT REPORTED OUTSIDE THE LAB. THE PT SAMPLES WERE RETESTED AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. 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