BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECAT ACCEL

    MDR report key: 840120 · Received February 16, 2007

    Report

    Report Number
    1034973-2007-00002
    Event Type
    Other
    Date Received
    February 16, 2007
    Date of Event
    December 15, 2006
    Report Date
    January 18, 2007
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL APPLICATIONS AND SOFTWARE ENGINEERING WERE ABLE TO DUPLICATE THE REPORTED COMPLAINT FROM THE CUSTOMER. AS A RESULT OF THEIR INVESTIGATION, A SOFTWARE MODIFICATION PATCH WILL BE RELEASED TO THE FIELD TO CORRECT THIS ISSUE. IN THE INTERIM, A WORKAROUND WILL BE COMMUNICATED TO OUR CUSTOMERS. THERE IS THE POTENTIAL THAT AN INCORRECT SUV COULD BE MISINTERPRETED AND IMPACT A PT'S TREATMENT PLAN. HOWEVER, IT SHOULD BE NOTED THAT SIEMENS MEDICAL SOLUTIONS USA, INC. HAS NOT RECEIVED ANY REPORTS WHICH INDICATE THIS HAS OCCURRED.

    Description of Event or Problem · 1

    WHEN A WHOLE-BODY PET SCAN IS ACQUIRED IN TTTTEEEE MODE, THE ATTENUATION CORRECTED PET IMAGES ARE DECAY CORRECTED BACK TO THE SCAN START TIME OF THE FIRST TRANSMISSION SCAN. HOWEVER, WHEN THE ATTENUATION CORRECTED PET IMAGES ARE ADDED INTO THE SYSTEMS DATABASE, THE SCAN START TIME OF THE FIRST EMISSION SCAN IS INSERTED INTO THE FILE, INSTEAD OF THE SCAN START TIME OF THE FIRST TRANSMISSION SCAN. WHILE THIS DOES NOT EFFECT THE ABSOLUTE QUANTIFICATION (EQ/CC) OF THE ATTENUATION CORRECTED PET DATA, IT CAN EFFECT THE STANDARD UPTAKE VALUE (SUV) CALCULATIONS. THE SUV CALCULATION IS EFFECTED BECAUSE THE INJECTED PT DOSE IS DECAY CORRECTED TO THE WRONG SCAN START TIME (EMISSION SCAN START TIME INSTEAD OF TRANSMISSION SCAN START TIME). THE PERCENT ERROR IN THE SUV CALCULATION IS DEPENDENT ON THE TIME DIFFERENCE BETWEEN THE TRANSMISSION AND EMISSION SCAN START TIMES AND THE HALF-LIFE OF THE ISOTOPE USED FOR THE EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECAT ACCEL PET SCANNER KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 3600211-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other