BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGRAPHY TRUEPOINT PET-CT W/RB-82

    MDR report key: 2052901 · Received April 7, 2011

    Report

    Report Number
    MW5020212
    Event Type
    Injury
    Date Received
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    SIEMENS MEDICAL, BRACCO DIAGNOSTICS
    Product Code
    KPS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UTILIZATION OF THE BRACCO RB-82 CARDIAC IMAGING AGENT IN CONJUNCTION WITH A SIEMENS BIOGRAPHY TRUEPOINT PET-CT IN 35 PATIENTS CAUSED AN ARTIFACTUAL SEPTAL DEFECT IN 23 PATIENTS, REQUIRING ADD'L IMAGING INVOLVING IONIZING RADIATION. SCANS WERE PERFORMED OVER THE PERIOD (B)(6) 2008 AND (B)(6) 2009. THE SCAN AND RECONSTRUCTION PROCEDURES RECOMMENDED BY SIEMENS WERE USED. IT WAS THOUGHT THAT THE ARTIFACT WAS CAUSED BY THE PROCESSING PROTOCOL. HOWEVER, DIFFERENT PROTOCOLS USED BY OTHER FACILITIES APPEAR ALSO TO CAUSE THIS ARTIFACT. A NUMBER OF DIFFERENT RECONSTRUCTION ALGORITHMS AND APPROACHES ARE AVAILABLE ON THE SIEMENS EQUIPMENT. ADDITIONALLY, OTHER RECONSTRUCTION PACKAGES HAVE BEEN DEVELOPED BY OTHER INSTITUTIONS. DURING APPLICATIONS TRAINING, SIEMENS PERSONNEL INSTRUCTED STAFF TO USE AN ALGORITHM CALLED (B)(4) FOR RECONSTRUCTION OF RB-82 IMAGES WITH SOME SPECIFIC PARAMETER SETTINGS. THIS RESULTED IN THE OBSERVED ARTIFACTS. WHEN SIEMENS RETURNED AT THE REQUEST OF THIS FACILITY, THEY INDICATED THAT TWO SPECIFIC APPROACHES CALLED FILTERED BACK PROJECTION OR 2-DIMENSIONAL ITERATIVE RECONSTRUCTION ARE APPROPRIATE FOR RB-82 STUDIES, NOT THE SIEMENS (B)(4), WHICH IS A 3-DIMENSIONAL ITERATIVE PROCESS. THESE ALGORITHMS WERE USED ON SEVERAL CASES AND APPEARED TO GIVE IMPROVED RESULTS. ADDITIONALLY, THE FACILITY INVESTIGATED THE POSSIBILITY OF USING RECONSTRUCTION PACKAGES DEVELOPED BY (B)(6) MEDICAL CENTER OR THE (B)(6), WHO USE SIMILAR, BUT NOT IDENTICAL SYSTEMS. IT APPEARED THAT EITHER OF THESE PACKAGES PROVIDED SUPERIOR PERFORMANCE TO THE SIEMENS ALGORITHMS. IT WAS BELIEVED THAT CLINICAL SCANNING COULD BE RESUMED USING ONE OF THESE OTHER ALGORITHMS. FURTHER INVESTIGATION, HOWEVER, BEGAN TO PLACE DOUBT ON THIS BELIEF. IT WAS REPORTED BY PERSONAL VERBAL COMMUNICATION THAT BOTH OF THESE FACILITIES WERE HAVING ISSUES WITH THEIR IMAGING THAT APPEARED TO BE SIMILAR ARTIFACTS. THIS ARTIFACT HAS NOT BEEN RESOLVED, NOR HAS IT BEEN PUBLICLY ANNOUNCED BY SIEMENS. RECENT INFO SEEMS TO INDICATE THAT IT MIGHT BE A PROBLEM WITH THE SCANNER PROPERLY HANDLING ONE OF THE RADIATIONS EMITTED BY THE RB-82 DECAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGRAPHY TRUEPOINT PET-CT W/RB-82 PET-CT KPS SIEMENS MEDICAL, BRACCO DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other