BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTX

    MDR report key: 11195257 · Received January 15, 2021

    Report

    Report Number
    MW5098869
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 18, 2020
    Report Date
    January 14, 2021
    Product Code
    POK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    QUANTX SOFTWARE MAY ENTER INTO AN ERROR STATE IN WHICH MEDICAL IMAGES DISPLAYED TO THE USER ARE FROZEN IN PLACE. QUANTX SOFTWARE VERSION (B)(4) ENTER INTO AN ERROR STATE IN WHICH ONE VIEWPORT IS FROZEN IN PLACE. WHEN THIS ERROR OCCURS, QUANTX STOPS RESPONDING TO USER INPUTS TO MODIFY THE DISPLAY OF THE FROZEN IMAGE. THIS ERROR STATE IS REACHED THROUGH A SPECIFIC SEQUENCE OF KEYSTROKES AND MOUSE ACTIONS. ONCE THE ONE IMAGE IS FROZEN IN A VIEWPORT IT REMAINS FROZEN. IT WILL ALSO REMAIN FROZEN IF A USER ATTEMPTS TO LOAD NEW PATIENT DATA. AS A RESULT OF THIS ERROR, USERS OF QUANTX WILL SEE AN INCORRECT OR INCOMPLETE IMAGE IN THE ONE FROZEN VIEWPORT. THIS ERROR STATE CAN BE RESOLVED BY CLOSING AND RELAUNCHING THE APPLICATION. THIS SOFTWARE LOGIC ERROR IS THE RESULT OF CODE THAT DOES NOT PROPERLY MODIFY IMAGE DISPLAY WHEN THE SPECIFIC SEQUENCE OF FUNCTIONS ARE CALLED OR CLEAR DATA HELD IN MEMORY WHEN NEW PATIENT DATA IS LOADED. THIS ERROR WAS OBSERVED BY QLARITY STAFF DURING A TRAINING SESSION AND DID NOT INVOLVE VIEWING LIVE PATIENT DATA. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78898 QUANTX COMPUTER-ASSISTED DIAGNOSTIC SOFTWARE FOR LESIONS SUSPICIOUS FOR CANCER POK VERSION 2.4, 2.4.1

    Patients

    Seq Age Sex Outcome Treatment
    1