MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM REGISTRATION MANAGEMENT; SOFTWARE

Model Number 2015.01 - 2018.01

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2018

Event Type  malfunction  

Manufacturer Narrative

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.

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 registration management®, 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 registration management.This issue involves cerner millennium registration management and occurs when a new encounter is added for a patient that already has an existing encounter with an mrn during a rolling upgrade.When this occurs, a new, additional mrn is assigned to the encounter when it is saved.The additional mrn is assigned to the new encounter, and is displayed on registration documents (such as armbands and facesheets) and in cerner millennium® powerchart®.If the mrn in the encounter was modified, the original mrn is displayed in the encounter but both mrns are displayed inconsistently throughout cerner millennium and on associated printed documents.This issue could lead to a delay in patient care if the mrn associated to an order (i.E.Medication, blood product, etc.) did not match the information on the patient's armband or other patient identifiers presented.Cerner has not received communication on adverse patient events as a result of this issue.

Manufacturer Narrative

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 july 10, 2018 to all potentially impacted client sites.The software notification includes a description of the issue 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.

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 registration management®, 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 registration management.This issue involves cerner millennium registration management and occurs when a new encounter is added for a patient that already has an existing encounter with an mrn during a rolling upgrade.When this occurs, a new, additional mrn is assigned to the encounter when it is saved.The additional mrn is assigned to the new encounter, and is displayed on registration documents (such as armbands and facesheets) and in cerner millennium® powerchart®.If the mrn in the encounter was modified, the original mrn is displayed in the encounter but both mrns are displayed inconsistently throughout cerner millennium and on associated printed documents.This issue could lead to a delay in patient care if the mrn associated to an order (i.E.Medication, blood product, etc.) did not match the information on the patient's armband or other patient identifiers presented.Cerner has not received communication on adverse patient events as a result of this issue.Cerner has not received communication on adverse patient events as a result of this issue.

• Brand Name: CERNER MILLENNIUM REGISTRATION MANAGEMENT
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 7421951
• MDR Text Key: 105645731
• Report Number: 1931259-2018-00004
• 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: Notification
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 03/14/2018
• Supplement Dates FDA Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1