MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM DYNAMIC DOCUMENTATION; SOFTWARE

Model Number 2015.01 - 2018.01

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on (b)(6) 2018 to all potentially impacted client sites.The software notification includes a description of the issue, alternative workflows and 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.

Event Description

The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's millennium dynamic documentation®, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner's millennium dynamic documentation® medication reconciliation.The issue involves cerner millennium dynamic documentation and affects users that utilize medication reconciliation to create patients' discharge paperwork.In cerner millennium, the med_list_apply_org_security preference is not recognized when a user creates a note from a standard template.This preference allows an override of organizational security for medications and when this issue occurs, only medications that are within the current user's organizational security parameters will be displayed on the medication reconciliation.Medications outside the user's organizational parameters would be omitted.Patient care could be adversely affected if all medications are not displayed on the medication reconciliation as expected.This issue could result in patients not taking medication as prescribed.Cerner has not received communication on any adverse patient events as a result of this issue.

Event Description

The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's millennium dynamic documentation®, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner's millennium dynamic documentation® medication reconciliation.The issue involves cerner millennium dynamic documentation and affects users that utilize medication reconciliation to create patients' discharge paperwork.In cerner millennium, the med_list_apply_org_security preference is not recognized when a user creates a note from a standard template.This preference allows an override of organizational security for medications and when this issue occurs, only medications that are within the current user's organizational security parameters will be displayed on the medication reconciliation.Medications outside the user's organizational parameters would be omitted.Patient care could be adversely affected if all medications are not displayed on the medication reconciliation as expected.This issue could result in patients not taking medication as prescribed.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on may 11, 2018 to all potentially impacted client sites.The software notification includes a description of the issue, alternative workflows and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner distributed a flash notification on october 4, 2018 to all potentially impacted client sites.The software notification includes a description of the issue, alternative workflows and 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.

• Brand Name: CERNER MILLENNIUM DYNAMIC DOCUMENTATION
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 7510185
• MDR Text Key: 108254628
• Report Number: 1931259-2018-00007
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2015.01 - 2018.01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1