BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CC CREATININE

    MDR report key: 1032663 · Received April 22, 2008

    Report

    Report Number
    2018433-2008-00057
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CGX
    PMA / PMN Number
    K981799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 CUSTOMER STATES THAT DISCREPANT PT RESULTS WERE GENERATED BY THE CLINICAL CHEMISTRY CREATININE ASSAY TESTED ON THE ARCHITECT C8000 ANALYZER. THIS PT GENERATED AN INITIAL RESULT OF 4.27 MG/DL. THE RESULT WAS NOT REPORTED FROM THE LAB. THE SAMPLE RETESTED AT 0.72 MG/DL. CONTROLS WERE WITHIN SPECS. THERE IS NO IMPACT TO PT MGMT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CC CREATININE QUANTITATIVE DETERMINATION OF CREATININE CGX ABBOTT MANUFACTURING, INC. NA 58076HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ARCHITECT C8000 PRC MOD LIST#: 1G06-01