BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2258826 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03383
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT ON (B)(4) 2008 AND DISCOVERED THE WASH BUFFER SUPPLY TUBING TO THE WASH VALVE WAS CRACKED. THE FSE REPLACED THE CRACKED TUBING AND ALL VERIFICATION TESTING PASSED WITHIN SPECS. THE CUSTOMER RETESTED ALL PATIENT SAMPLES AFTER THE FSE COMPLETED THE SERVICE REPAIR. NOTE: THE CRACK IN THE WASH BUFFER SUPPLY TUBING WOULD ALLOW AIR INTO THE WASH VALVE AND PRECISION VALVE, THUS CAUSING ERRATIC RESULTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM JANUARY 1, 2008 THROUGH OCTOBER 23, 2010 FOR ADD'L REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDRS: 212870-2011-03327, 03328 AND 03382.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TOTAL THYROXINE (TT4) RESULTS FOR ONE PT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THIS IS REPORT NUMBER FOUR OF FOUR. THE ELEVATED RESULTS WERE DISCORDANT TO A PREVIOUSLY TESTED TT4 SAMPLE RESULT. IT IS UNK IF THE ELEVATED RESULTS WERE RELEASED OUT OF THE LAB. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT.

    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 73 YR ACCESS TOTAL T4