BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2160986 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01889
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    December 7, 2008
    Report Date
    December 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    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 ONSITE ON (B)(6) 2008 TO INVESTIGATE THE EVENT. THE FSE PERFORMED A HIGH SENSITIVITY (HS) SYSTEM CHECK, LOW LEVEL QUALITY CONTROL (QC) PRECISION AND SYSTEM CHECK AND ALL PASSED WITHIN INSTRUMENT SPECS. NO HARDWARE ISSUES WERE FOUND. THE QUALITY CONTROL (QC) DATA WERE REVIEWED AND THEY WERE WITHIN SPEC PRIOR TO THE EVENT. THE SYSTEM CHECKS PERFORMED ON (B)(6) 2008 DATA WERE REVIEWED AND THEY WERE WITHIN INSTRUMENT SPECS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS IS TWO OF TWO SEPARATE MDR REPORTS RELATED TO TWO PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON TWO DIFFERENT DAYS. REFERENCE MDR NUMBERS: 2122870-2011-01890 FOR ALL EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) ON (B)(6) 2008 IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PTS. THE PT SAMPLES WERE RETESTED AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUSLY ELEVATED 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 ACCUTNI