BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINICAL CHEMISTRY IRON

    MDR report key: 1016481 · Received March 18, 2008

    Report

    Report Number
    2018433-2008-00031
    Event Type
    Other
    Date Received
    March 18, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    CFM
    PMA / PMN Number
    K981581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, NO RESULTS OR CONCLUSION CAN BE DRAWN. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A DEPRESSED ARCHITECT C8000 IRON RESULT ON A PT THAT DID NOT CORRELATE WITH OTHER METHODS. THE PT TESTED ARCHITECT C8000 IRON = 7 UG/DL, ROCHE METHOD = 42 UG/DL AND KOVALENTE METHOD = 40 UG/DL. THE DEPRESSED ARCHITECT C8000 IRON RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY IRON QUANTITATION OF IRON CFM ABBOTT LABORATORIES, INC. NA 56055HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR LIST 1G06-62| C8000 ANALYZER