BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2121827 · Received May 20, 2011

    Report

    Report Number
    2122870-2011-01144
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    June 22, 2010
    Report Date
    June 28, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGN
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER'S QUALITY CONTROL (QC) CHARTS, THREE LEVELS OF QC ARE TESTED DAILY. THE ASSAY HAS BEEN +/- 2 STANDARD DEVIATION (SD) OF THE CUSTOMER'S ESTABLISHED MEAN PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK REPORT WAS SUPPLIED, AND ALL PORTIONS WERE WELL WITHIN THE PUBLISHED SPECS. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AND CONFIRMED A REAGENT PACK WAS SHARED BETWEEN THE ACCESS 2 IMMUNOASSAY SYSTEM AND THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE OPERATOR'S GUIDE SPECIFICALLY STATES IF A PARTIALLY USED REAGENT PACK IS LOADED ON A DIFFERENT SYSTEM OR WORKGROUP, IT WILL BE INVENTORIED AS A FULL PACK AND INACCURATE RESULTS MAY OCCUR. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 TO (B)(6) 2010 FOR ADD'L REPORTABLE EVENTS. THIS MEDWATCH IS RELATED TO THE ORIGINAL MDR 2122870-2010-00365, PT NUMBER ONE. RELATED MDRS: 2122870-2011-01142, -01143, -01146.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG) RESULTS WITHIN THE NORMAL RANGE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM ON FIVE PTS' SAMPLES. THIS REPORT REFERS TO PT NUMBER FOUR. THE SAMPLES WERE RETESTED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM WITH A NEW REAGENT PACK AND RECOVERED RESULTS ABOVE THE NORMAL REFERENCE RANGE. THE CUSTOMER CONFIRMED A USED BHCG REAGENT PACK FROM THE DXI 800 SYSTEM WAS LOADED INTO THE ACCESS 2 SYSTEM AND PRODUCED THE ERRONEOUS RESULTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNK OF PT INJURY OR CHANGE TO PT ATTRIBUTED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND ASSESSED THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM CGN BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM| ACCESS TOTAL BHCG