BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORDICICE

    MDR report key: 4902600 · Received June 26, 2015

    Report

    Report Number
    3006738448-2015-00001
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 25, 2015
    Manufacturer
    NORDICNEUROLAB AS
    Product Code
    LLZ
    PMA / PMN Number
    K090546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVELOPMENT TEAM DURING INTERNAL TESTING DISCOVERED A BUG CONCERNING HANDLING OF COREGISTRATION FOR BOLD SERIES. THIS BUG WAS VERIFIED IN CURRENT VERSION 2.3.14. ALL USERS WILL BE NOTIFIED TO STOP USING THE BOLD MODULE IN NORDICICE AND CONTACT NORDICNEUROLAB FOR FURTHER INSTRUCTIONS FOR BLOCKING THE BOLD MODULE FOR FURTHER USE. AFFECTED USERS WILL BE OFFERED A TRANSITION TO NORDICBRAINEX ((B)(4)) WHICH IS OPTIMIZED FOR THE BOLD WORKFLOW. RISK EVALUATION: THE PROBLEM CAN POTENTIALLY CAUSE A MISALIGNMENT OF THE BOLD ACTIVATIONS IN RELATIONS TO THE STRUCTURAL UNDERLAY. GIVEN THAT THE HEAD MOTION CORRECTED BY THE COREGISTRATION IS USUALLY SMALL, THE EFFECT OF THIS BUG IS EQUALLY SMALL. THE MOST COMMON SIZE OF MISALIGNMENTS ARE ON THE SAME ORDER OF MAGNITUDE AS THE INHERENT UNCERTAINTIES OF THE ANALYSIS ITSELF, WHICH MAKES IT UNLIKELY THAT IS SHOULD INTRODUCE ANY ADDED RISK PATIENT HARM IN THE LAST STEP. FOR LARGER MISALIGNMENTS, IT IS UNLIKELY THAT THE ERROR IS NOT DETECTED BY THE USER.

    Description of Event or Problem · 1

    THE BUG WAS DISCOVERED DURING TESTING INTERNALLY IN THE MANUFACTURER'S FACILITY. THE BUG WAS EVALUATED TO HAVE PATIENT RISK. THE BUG CAUSES BOLD ACTIVATIONS MAPS TO BE VISUALIZED AS OVERLAYS WITHOUT TAKING THE COREGISTRATION INTO ACCOUNT. ANY OUTPUT CREATED FROM THESE ACTIVATION MAPS AS OVERLAYS WILL NOT BE ADJUSTED ACCORDING TO THE COREGISTRATION. THE BUG ONLY AFFECTS THE BOLD FMRI ANALYSIS AND NO OTHER MODULES OR ANALYSES. FURTHERMORE, THE PROBLEM WILL NOT OCCUR IF THE BOLD/DTI WIZARD IS USED, OR IF COREGISTRATION IS DONE BEFORE THE BOLD MODULE ANALYSIS IS STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416388 NORDICICE PACS LLZ NORDICNEUROLAB AS

    Patients

    Seq Age Sex Outcome Treatment
    1