BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON RADIOLOGY

    MDR report key: 3347534 · Received August 21, 2013

    Report

    Report Number
    8022257-2013-00008
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A CLINICAL EVAL, MCKESSON HAS DETERMINED THAT THERE IS A POSSIBILITY THAT A TECHNOLOGIST AND/OR RADIOLOGIST MAY PROCEED WITH A PROCEDURE AND INJECT THE PT WITH CONTRAST MEDIA. MCKESSON HAS DETERMINED THAT THIS PROBLEM IS CAUSED BY AN ERROR IN THE USER INTERFACE IMPLEMENTATION RESULTING IN THE INFORMATION BEING DISABLED. 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

    MCKESSON MEDICAL IMAGING COMPANY HAS IDENTIFIED INTERNALLY THAT WHEN MERGING TWO PT RECORDS INTO ONE PT RECORD USING MCKESSON RADIOLOGY 12.0, THE RESULTING PT RECORD IS MISSING THE CONTRAST ALLERGY INFORMATION. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406866 MCKESSON RADIOLOGY LLZ MCKESSON MEDICAL IMAGING COMPANY 12.0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK