BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERNER MILLENNIUM ANATOMIC PATHOLOGY

    MDR report key: 7427171 · Received April 12, 2018

    Report

    Report Number
    1931259-2018-00005
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Date of Event
    January 11, 2010
    Report Date
    September 12, 2018
    Manufacturer
    CERNER CORPORATION
    Product Code
    JQP
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CERNER DISTRIBUTED A FLASH NOTIFICATION ON APRIL 6, 2018 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE AND EXPLAINS THAT A SOFTWARE MODIFICATION IS BEING DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER DISTRIBUTED AN UPDATED FLASH NOTIFICATION ON AUGUST 14, 2018 TO COMMUNICATE THAT A SOFTWARE MODIFICATION HAS BEEN DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER CORPORATION CONSIDERS THIS ISSUE TO BE RESOLVED AND NO FURTHER NARRATIVE IS REQUIRED FOR FOLLOW-UP.

    Description of Event or Problem · 0

    THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S MILLENNIUM ANATOMIC PATHOLOGY; CLASS I, PRODUCT CODE JQP. THIS ISSUE INVOLVES CERNER MILLENNIUM ANATOMIC PATHOLOGY AND OCCURS WHEN AN ORDER IS PLACED FOR A PATIENT USING AN ANATOMIC PATHOLOGY ORDERABLE ITEM THAT HAS AN ORDER COMMENT ASSOCIATED WITH A JULIAN ACCESSION NUMBER. IF THIS ORDER IS ADDED TO AN EXISTING OPEN CASE FOR THE SAME PATIENT, THE ORDER COMMENT ASSOCIATED WITH THE JULIAN ACCESSION NUMBER IS NOT DISPLAYED. THIS ISSUE COULD RESULT IN A PATHOLOGIST PROCESSING SPECIMENS WITHOUT KNOWLEDGE OF THE ASSOCIATED ORDER COMMENTS. CERNER RECEIVED A REPORT THAT, DUE TO THE ORDER COMMENTS NOT BEING AVAILABLE, AN INCOMPLETE REPORT WAS GENERATED AND THE PATHOLOGIST PROCESSED SPECIMENS WITHOUT KNOWLEDGE OF THE ASSOCIATED ORDER COMMENTS.

    Additional Manufacturer Narrative · 1

    CERNER DISTRIBUTED A FLASH NOTIFICATION ON APRIL 6, 2018 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE AND EXPLAINS THAT A SOFTWARE MODIFICATION IS BEING DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER CORPORATION WILL PROVIDE A FOLLOW-UP REPORT WHEN THE SOFTWARE MODIFICATION IS AVAILABLE.

    Description of Event or Problem · 1

    THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S MILLENNIUM ANATOMIC PATHOLOGY; CLASS I, PRODUCT CODE JQP. THIS ISSUE INVOLVES CERNER MILLENNIUM ANATOMIC PATHOLOGY AND OCCURS WHEN AN ORDER IS PLACED FOR A PATIENT USING AN ANATOMIC PATHOLOGY ORDERABLE ITEM THAT HAS AN ORDER COMMENT ASSOCIATED WITH A JULIAN ACCESSION NUMBER. IF THIS ORDER IS ADDED TO AN EXISTING OPEN CASE FOR THE SAME PATIENT, THE ORDER COMMENT ASSOCIATED WITH THE JULIAN ACCESSION NUMBER IS NOT DISPLAYED. THIS ISSUE COULD RESULT IN A PATHOLOGIST PROCESSING SPECIMENS WITHOUT KNOWLEDGE OF THE ASSOCIATED ORDER COMMENTS. CERNER RECEIVED A REPORT THAT, DUE TO THE ORDER COMMENTS NOT BEING AVAILABLE, AN INCOMPLETE REPORT WAS GENERATED AND THE PATHOLOGIST PROCESSED SPECIMENS WITHOUT KNOWLEDGE OF THE ASSOCIATED ORDER COMMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267143 CERNER MILLENNIUM ANATOMIC PATHOLOGY SOFTWARE JQP CERNER CORPORATION 2007.19 THROUGH 2018.01 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1