BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 3528196 · Received December 12, 2013

    Report

    Report Number
    8022257-2013-00010
    Event Type
    Other
    Date Received
    December 12, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 11, 2013
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ALLOWS THE STATUS OF A STUDY TO BE MARKED AS "PERFORMED", "REVIEWED", "NEEDS OVER-READ", "DICTATED", OR "REPORTED." USERS AT THE REPORTING FACILITY ARE GRANTED PERMISSIONS TO CHANGE THE STATUS OF A STUDY BASED ON ESTABLISHED CONFIGURATION SETTINGS. UNDER NORMAL OPERATING CONDITIONS A TECHNOLOGIST AT THE REPORTING FACILITY HAS PERMISSIONS TO CHANGE THE STATUS OF STUDIES FROM "PERFORMED" TO "REVIEWED." THE REPORTING FACILITY INDICATED THAT TECHNOLOGISTS ARE TRAINED ONLY TO MARK STUDIES AS "REVIEWED." WHEN THE HORIZON MEDICAL IMAGING AUTHORIZATION SERVICE USED TO MANAGE USER PERMISSIONS IS INOPERATIVE OR INACCESSIBLE, THE SYSTEM IS DESIGNED TO ENSURE HIGH AVAILABILITY OF CRITICAL FUNCTIONS TO ENABLE CARE PROVIDERS TO ACCESS STUDIES. UNDER THESE CONDITIONS, THE SYSTEM GRANTS FULL PERMISSIONS TO ALL USERS TO ENSURE THAT CRITICAL FEATURES REMAIN AVAILABLE. WHEN OPERATING IN THIS MODE, THE USER ARE PROVIDED WITH MENU OPTIONS TO MARK THE STUDY AS "REVIEWED", "NEEDS OVER-READ", "DICTATED", OR "REPORTED." BASED ON OUR INVESTIGATION, WHICH INCLUDED A REVIEW OF THE SYSTEM ACTIVITY LOGS FROM THE REPORTING FACILITY, THE TECHNOLOGIST WAS GRANTED FULL PERMISSIONS, AS THE AUTHORIZATION PROCESS WAS INACCESSIBLE DUE TO A SYSTEM COMMUNICATION ISSUE. THE SYSTEM GRANTED THOSE FULL PERMISSIONS TO THE TECHNOLOGIST, AS DESIGNED. THE TECHNOLOGIST INADVERTENTLY SELECTED THE INCORRECT STATUS FOR THE PT STUDY, MARKING IT AS "REPORTED" INSTEAD OF "REVIEWED", RESULTING IN AN ALLEGED DELAY SENDING THE STUDY TO THE RADIOLOGIST TO READ. FURTHER INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE PACS ADMINISTRATOR FROM THE REPORTING FACILITY ALLEGED THAT A TECHNOLOGIST INADVERTENTLY MARKED A STUDY AS "REPORTED", AND THAT THE RADIOLOGIST DID NOT RECEIVE THE STUDY CORRECTLY MARKED FOR REQUIRING A RADIOLOGY REVIEW UNTIL 3 DAYS LATER. IT IS ALLEGED THAT THE PT EXPERIENCED COMPLICATIONS WHILST BEING TREATED AT THE REPORTING FACILITY, BUT THAT THERE WAS NO HARM TO THE PT. (B)(4) HAS CONTACTED THE REPORTING FACILITY TO OBTAIN FURTHER INFO IN ITS INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651365 HORIZON MEDICAL IMAGING LLZ MCKESSON MEDICAL IMAGING COMPANY 11.8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other