BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY AW SUITE OPTION

    MDR report key: 1160667 · Received September 1, 2008

    Report

    Report Number
    3004526608-2008-00076
    Event Type
    Malfunction
    Date Received
    September 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 25, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED LATE, AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES. THIS ACTIVITY IS BEING COMPLETED AS PART OF A CORRECTIVE ACTION. THE REPORTED ISSUE IS BEING INVESTIGATED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A REPORTER EXPRESSED CONCERN THAT THE STANDARD UPTAKE VALUES (SUV) FOR POSITRON EMISSION TOMOGRAPHY (PET) ARE INCORRECT WHEN THE EXAMINATION WAS PERFORMED ON A SCANNER NOT MANUFACTURED BY GE HEALTHCARE. AS SUVS ARE USEFUL IN THE DETERMINATION OF THE MALIGNANCY OF A LESION, ACCURATE CALCULATIONS ARE EXPECTED. THERE WAS NO REPORT OF ADVERSE PATIENT OUTCOME OR DATA LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY AW SUITE OPTION RADIOLOGICAL SYSTEM, IMAGE PROCESSING LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS AW SUITE NA

    Patients

    Seq Age Sex Outcome Treatment
    1