BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORDICICE SOFTWARE

    MDR report key: 2894541 · Received December 20, 2010

    Report

    Report Number
    3006738448-2010-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Report Date
    December 17, 2010
    Manufacturer
    NORDICNEUROLAB AS
    Product Code
    LLZ
    PMA / PMN Number
    K090546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IN MOSAIC IMAGES FROM SIEMENS MR MACHINE THERE'S AN OPTION TO REVERSE SLICES WITHIN A MOSAIC IMAGE. THIS IS NOTED WITHIN A PRIVATE TAG IN THE HEADER. IN THE SOFTWARE INVOLVED THE INTERPRETATION OF THIS HEADER HAS NOT BEEN COMPLETELY CORRECT AND THIS MAY LEAD TO SITUATIONS WHERE THE SLICES MAY BE REVERSED. THIS HAPPENS WHEN THE IMAGES HAVE BEEN SET UP FOR REVERSAL, AND THE REVERSAL IS SPECIFIED TO BE IN A DIFFERENT DIRECTION THAT THE DATASET IN QUESTION. THE CONSEQUENCE OF THIS ERROR MAY BE LEFT-RIGHT, UP-DOWN AND ANTERIOR-POSTERIOR FLIPPING OF IMAGES.

    Description of Event or Problem · 1

    THE PROBLEM WAS DETECTED BY AN ENGINEER WHEN HE TESTED THE SOFTWARE PRODUCT NORDICBRAINEX V.1.0.4 AS AN EVALUATION OF THE SOFTWARE'S CAPABILITIES BEFORE BUYING THE PRODUCT. THE BUG HE DISCOVERED HAS ITS ROOT IN SOFTWARE CODE THAT IS SHARED BY THE SOFTWARE PRODUCT CALLED NORDICICE, AND THE ERROR IS THEREFORE PRESENT IN THIS PRODUCT. THE BUG WAS INTRODUCED IN NICE V.2.3.7 AND EXISTS IN THE LATER VERSIONS 2.3.8 - 2.3.10. THE BUG WAS INTRODUCED IN NBX IN V.1.0.1 AND EXISTS IN THE LATER VERSION 1.0.2 -1.0.4. THESE SOFTWARE PACKAGES HAVE BEEN IN USE AT MANY SITES WHERE THEY HAVE BEEN USED FOR ANALYSIS OF IMAGES FROM SIEMENS MACHINES USING THE MOSAIC FORMAT. HOWEVER, NO OTHER REPORTS HAVE BEEN RECEIVED BY THE MANUFACTURER ON THIS PROBLEM. WE THEREFORE BELIEVE THAT THE SPECIAL CONFIGURATION FOUND IN THE HEADER OF THE IMAGES FOR WHICH THE SOFTWARE SET UP A WRONG GEOMETRY IS VERY UNUSUAL. ANYWAY, TO AVOID POSSIBLE MISINTERPRETATIONS OF IMAGE DATA WITH REGARDS TO WHERE A CERTAIN ANATOMICAL STRUCTURE IS LOCATED WE SEND WARNING LETTERS TO ALL OF OUR CUSTOMERS. THE NEXT STEP FOR US WILL BE TO FIX THE SOFTWARE AND RELEASE A NEW VERSION. HOWEVER, TO DO THAT WE NEED TO OBTAIN MORE INFORMATION FROM SIEMENS ABOUT THE INTERPRETATION OF THE HEADER INFORMATION IN THE IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORDICICE SOFTWARE LLZ PACS LLZ NORDICNEUROLAB AS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other