BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 709146 · Received May 3, 2006

    Report

    Report Number
    2122870-2006-00099
    Event Type
    Other
    Date Received
    May 3, 2006
    Date of Event
    April 11, 2006
    Report Date
    May 3, 2006
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCU TNL) RESULT FROM A SINGLE PT SAMPLE THAT WAS GENERATED BY THE ACCCESS INSTRUMENT. AN INITIAL ACCU TNL RESULT WAS 5.9NG/ML. THE ACCU TNL RESULT WAS NOT REPORTED OUT OF THE LAB. THE CUSTOMER RETESTED THE PT ORIGINAL SAMPLE FOR ACCU TNL USING A NEW TUBE. THE REPEATED ACCU TNL RESULT WAS 0.01NG/ML. THE CUSTOMER RETESTED THE PT ORIGINAL SAMPLE 2ND TIME USING A 2ND NEW TUBE. THE 2ND REPEAT ACCU TNL RESULT WAS 0.01NG/ML. THE ACCU TNL RESULT WAS REPORT OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQURING MEDICAL INTERVENTION OR CHANGE TO 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 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. ACCESS IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA