BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTRICITY RA1000

    MDR report key: 1003823 · Received February 26, 2008

    Report

    Report Number
    3004526608-2008-00004
    Event Type
    Other
    Date Received
    February 26, 2008
    Date of Event
    October 26, 2007
    Report Date
    February 25, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED A COPY OF THE IMAGE THAT WAS MISINTERPRETED WITH THE MEASUREMENTS INDICATED ON THE IMAGE. THE MEASUREMENTS WERE CORRECTLY DISPLAYED. THE REPORTED ISSUE WAS CAUSED BY USER ERROR. THE ACTUAL READING ON THE IMAGE WAS: 1 A 92.1 MM2 MAX 129 MIN -66 X 27.9 SD 32.7 THIS A CORRECT READING. THE RADIOLOGIST INVOLVED MISINTERPRETED THE X 27.9 IN THE READING TO BE THE STANDARD DEVIATION. THE CORRECT INTERPRETATION OF X IS AVERAGE (X=AVG).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING A PATIENT UNDERWENT UNNECESSARY SURGERY BECAUSE THE REGION OF INTEREST (ROI) FIGURES ON GE CENTRICITY PACS WERE INCORRECTLY MISINTERPRETED BY THE RADIOLOGIST. A BENIGN RENAL CYST WAS MISINTERPRETED AS AN ENHANCING LESION, CONSISTENT WITH A "NEOPLASM". THE PATIENT UNNECESSARILY WENT TO THE OR AND HAD THE CYST REMOVED. THE NUMBERS IN THE REPORT SUGGEST THAT THE STANDARD DEVIATION OF THE PIXELS IN THE ROI WERE MIS-INTERPRETED AS HOUNSFIELD UNITS. THE ACTUAL READING ON THE IMAGE WAS: 1 A 92.1 MM2 MAX 129 MIN 66 X 27.9 SD 32.7. THE RADIOLOGIST MISINTERPRETED STANDARD DEVIATION OF THE PIXEL VALUES TO MEAN THE AVERAGE PIXEL VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY RA1000 RA1000 LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS RA1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other