BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 3164630 · Received June 10, 2013

    Report

    Report Number
    8022257-2013-00001
    Event Type
    Other
    Date Received
    June 10, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MEDICAL IMAGING COMPANY PERFORMED AN INVESTIGATION AND CONCLUDED THAT THE REPORTING CUSTOMER WAS USING A UNIQUE WORKFLOW THAT WAS BEYOND THE SCOPE OF THE CUSTOMARY RADIOLOGY WORK FLOW PRACTICES USED WITH HORIZON MEDICAL IMAGING. AT THE CUSTOMER SITE, NON-RADIOLOGIST PHYSICIANS (EX: PULMONOLOGISTS, NEUROLOGISTS ETC.) ARE AUTHORIZED SIMILAR REPORTING PRIVILEGES AS RADIOLOGISTS. HORIZON RADIOLOGY IMAGING CONTAINS A FEATURE THAT AUTOMATICALLY PLACES "BEING READ" LOCKS ON UNREAD STUDIES THAT ARE OPENED BY A PERSON WHO BELONGS TO AN ASSIGNED USER GROUP (I.E., RADIOLOGIST OR NON-RADIOLOGIST GROUP) AUTHORIZED TO MOVE THE STUDY TO A POST-INTERPRETATION STATUS (NEEDS OVER-READ, DICTATED, TRANSCRIBED, OR REPORTED). THIS FEATURE EXISTS TO PREVENT UNINTENDED STUDY DOUBLE-READS WHERE TWO INDIVIDUALS SIMULTANEOUSLY ISSUE DIAGNOSTIC REPORTS FOR THE SAME STUDY, EACH BEING UNAWARE OF THE OTHER. THE "BEING READ" LOCKS ARE ADVISORY IN NATURE (I.E., AN ICON IS SHOWN BESIDE THE STUDY IN THE WORK LIST AND A CAUTIONARY MESSAGE IS ISSUED IF THE STUDY IS OPENED BY A USER WHO MIGHT RISK DOUBLE-REPORTING) AND THUS USERS CAN CHOOSE TO ACCESS THE STUDY REGARDLESS. HOWEVER, IN ROUTINE PRACTICE, RADIOLOGISTS WILL AVOID OPENING STUDIES WITH A LOCK UNLESS SPECIFICALLY REQUESTED TO DO SO, BASED ON THE ASSUMPTION THAT ANOTHER RADIOLOGIST IS ALREADY PRODUCING A REPORT FOR THE STUDY. ADDITIONALLY, SOME RADIOLOGISTS CHOOSE TO FILTER OUT "BEING READ" STUDIES FROM THEIR WORK LIST SO THAT THEY DO NOT APPEAR IN THEIR ROUTINE WORKFLOW. A DELAY IN DIAGNOSIS COULD POTENTIALLY OCCUR WHEN THE NON-RADIOLOGIST PHYSICIAN WITH IDENTICAL REPORTING PRIVILEGES AS A RADIOLOGIST OPENS A STUDY FOR VIEWING PURPOSES ONLY WITH NO INTENTION OF CREATING A REPORT. IF THE NON-RADIOLOGIST PHYSICIAN SIMPLY OPENS THE STUDY FOR A BRIEF VIEW AND CLOSES THE STUDY IMMEDIATELY, THIS POTENTIAL DOES NOT EXIST AS THE LOCK APPEARS BRIEFLY AND THEN IS IMMEDIATELY REMOVED. HOWEVER, IF THE NON-RADIOLOGIST PHYSICIAN LEAVES THE STUDY OPEN FOR AN EXTENDED PERIOD OF TIME, RADIOLOGISTS MAY AVOID INTERPRETING THE STUDY BASED ON AN ASSUMPTION THAT ANOTHER COLLEAGUE IS ALREADY REPORTING IT. MCKESSON MEDICAL IMAGING COMPANY NOTIFIED THE CUSTOMER SITE OF HOW THEY CAN PERFORM A CONFIGURATION CHANGE TO ADDRESS THEIR UNIQUE WORKFLOW BY REMOVING THE LOCKING PERMISSION FOR NON-RADIOLOGIST PHYSICIANS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE MANAGER OF RADIOLOGY INFORMATION SOLUTIONS AT A CUSTOMER SITE OF A WORK FLOW CONDITION EXISTENT AT THEIR SITE THAT COULD LEAD TO THE POTENTIAL DELAY OF RADIOLOGY STUDY INTERPRETATIONS. THE USER DEFINED WORKFLOW ALLOWS FOR THE AUTHORIZATION OF NON-RADIOLOGIST PHYSICIANS TO CREATE DIAGNOSTIC REPORTS IN HORIZON MEDICAL IMAGING FOR SOME STUDIES THAT WOULD LEAD A SUBSEQUENT READING RADIOLOGIST TO DELAY INTERPRETATION OF THOSE STUDIES BECAUSE THEY INCORRECTLY BELIEVE THAT ANOTHER RADIOLOGIST IS ALREADY INTERPRETING THOSE STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261472 HORIZON MEDICAL IMAGING LLZ MCKESSON MEDICAL IMAGING COMPANY 11.6

    Patients

    Seq Age Sex Outcome Treatment
    1