BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2320401 · Received October 28, 2011

    Report

    Report Number
    2122870-2011-04927
    Event Type
    Malfunction
    Date Received
    October 28, 2011
    Date of Event
    March 5, 2009
    Report Date
    March 5, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2009, TO INVESTIGATE THE EVENT. THE FSE PERFORMED A 60 REPETITION PRECISION RUN WITH RESULTS THAT MET PUBLISHED PERFORMANCE SPECIFICATIONS. ALSO, THE FSE RAN A TWENTY REPETITION PRECISION RUN WITH TWO PT SAMPLES THAT ALSO RESULTED WITHIN SPECIFICATIONS. THE CPLS INVESTIGATION REVEALED THAT THE PT'S SAMPLE WAS LIPEMIC UPON RECEIPT. CPLS CENTRIFUGED THE SAMPLE AT 10000 RCF FOR 20 MINUTES TWICE AND WAS UNABLE TO CLEAR THE SAMPLE OF THE LIPEMIA. ALTHOUGH THE SAMPLE QUALITY IS A LIKELY CONTRIBUTING FACTOR, NO CLEAR ROOT CAUSE COULD BE DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 THROUGH OCTOBER 23, 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED FREE T4 RESULT GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PT. THE PT SAMPLES WERE RETESTED AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LAB. THE CUSTOMER SENT THE SAMPLE TO BCI CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER INVESTIGATION. 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS FREE T4