BEUDAMED
    FDA Adverse Event Summary report: N

    MCKESSON RADIOLOGY

    MDR report key: 3815410 · Received March 27, 2014

    Report

    Report Number
    8022257-2014-00003
    Date Received
    March 27, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTING FACILITY INDICATED IS USING THE HIGH PRIORITY ICON FOR PEER REVIEW WORKFLOW. RANDOM STUDIES WITH STATUS OF REPORTED ARE SELECTED FOR PEER REVIEW USING MCKESSON RADIOLOGY STUDY LIST. THE STUDIES ARE REPORTED AND SIGNED BY AN ACCREDITED RADIOLOGIST. SITE USES DIFFERENT FILTERS AND REASONS TO NOMINATE A STUDY FOR PEER REVIEW. THE CRITERIA FOR STUDY SELECTION VARY. ONCE THE STUDY IS SELECTED FOR PEER REVIEW, THE CUSTOMER CHANGES THE STATUS OF THE STUDY TO "REVIEWED" AND MARK THEM AS HIGH PRIORITY. THE HIGH PRIORITY ICON IS AN INDICATOR FOR THE DOCTORS (RADIOLOGIST) TO DO A PEER REVIEW ON THE STUDY. MCKESSON MEDICAL IMAGING COMPANY COMPLETED AN INVESTIGATION AND CONCLUDED THAT THE SYSTEM MALFUNCTIONED. THE HIGH PRIORITY ALERT ICON IS ONLY DISPLAYED WHEN THERE IS ALSO A STAT STUDY PRESENT IN THE MCKESSON RADIOLOGY STUDY LIST. WHEN THE HIGH PRIORITY ALERT ICON IS NOT DISPLAYED AS INTENDED, THERE IS POTENTIAL FOR A DELAY IN CARE. MCKESSON MEDICAL IMAGING COMPANY CUSTOMER SUPPORT WILL WORK WITH POTENTIALLY AFFECTED CUSTOMERS TO APPLY A SOFTWARE UPDATE TO MCKESSON RADIOLOGY 12.0 FOR CORRECTING THE ERROR IDENTIFIED.

    Description of Event or Problem · 1

    THE REPORTING FACILITY INDICATED THAT THE HIGH PRIORITY ALERT ICON DID NOT DISPLAY ON THE MCKESSON RADIOLOGY STUDY LIST, AS EXPECTED. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179925 MCKESSON RADIOLOGY PICTURE ARCHIVING AND COMM. SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 12.0

    Patients

    Seq Age Sex Outcome Treatment
    1 UKN