BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 643306 · Received October 4, 2005

    Report

    Report Number
    2122870-2005-00150
    Event Type
    Other
    Date Received
    October 4, 2005
    Date of Event
    September 8, 2005
    Report Date
    October 4, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCU TNL) RESULT FROM A SINGLE PT THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. THE CUSTOMER INDICATED THAT THE PT SAMPLE WAS TESTED IN DUPLICATE AND BOTH RESULTS WERE FLAGGED WITH A FATAL "QNS" FLAG WHICH SUPPRESSED THE ACCU TNL RESULTS. THE CUSTOMER RE-TESTED THE PT ORIGINAL SAMPLE IN DUPLICATE FOR ACCU TNL. THE ACCU TNL RESULTS WERE: 0.51NG/ML AND 0.00NG/ML. THE CUSTOMER INDICATED THAT THE PT ORIGINAL SAMPLES WAS RE-TESTED AGAIN IN DUPLICATE AND THE RESULTS WERE 0.00NG/ML AND 0.02NG/ML. THE ACCU TNLY RESULT OF 0.00NG/ML WAS REPORTED OUT OF THE LAB. NO ADDITIONAL INFORMATION REGARDING THIS EVENT WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER INDICATED THAT THERE WAS NO CHANGE IN PT TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DESCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. ACCESS 2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA