MAUDE Adverse Event Report: CERNER CORPORATION MPAGES - DISCERN EXPERT; SOFTWARE

Model Number REFER TO H10

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2020

Event Type  malfunction  

Manufacturer Narrative

Model number: mpages 6.12 through mpages 7.0.Clinical content (discern expert) december 2018 through march 2020.Cerner distributed a flash notification on 06.November.2020 to all potentially impacted client sites.The software notification includes a description of the issue 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 mpages® and discern expert®, 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 mpages® opioid review and discern expert®.The issue involves cerner millennium mpages or discern expert.This issue affects users that utilize the workflow opioid review mpages component to review information concerning a patient's history as related to opioid use.In cerner millennium, when the user orders opioid medications, not all medications that contain opioid are displayed.Medications that contain opioid as an ingredient but do not have the multum drug classes of either narcotic analgesics or narcotic analgesic combinations are not displaying in the workflow opioid review mpages component.These medications are also not considered in the discern expert rules for basic care: opioid review clinical content, which proactively identify patient-specific risks associated with ordering a narcotic analgesic.Patient care can be affected an opioid medication is prescribed to a patient based on inaccurate current opioid use information.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

D4: model number: mpages 6.12 through mpages 7.0.Clinical content (discern expert) (b)(6) 2018 through (b)(6) 2020 cerner distributed the initial flash notification on (b)(6) 2020 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner distributed the final flash notification on (b)(6) 2021 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 mpages® and discern expert®, 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 mpages® opioid review and discern expert®.The issue involves cerner millennium mpages or discern expert.This issue affects users that utilize the workflow opioid review mpages component to review information concerning a patient's history as related to opioid use.In cerner millennium, when the user orders opioid medications, not all medications that contain opioid are displayed.Medications that contain opioid as an ingredient but do not have the multum drug classes of either narcotic analgesics or narcotic analgesic combinations are not displaying in the workflow opioid review mpages component.These medications are also not considered in the discern expert rules for basic care: opioid review clinical content, which proactively identify patient-specific risks associated with ordering a narcotic analgesic.Patient care can be affected an opioid medication is prescribed to a patient based on inaccurate current opioid use information.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: MPAGES - DISCERN EXPERT
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 10843345
• MDR Text Key: 240294613
• Report Number: 1931259-2020-00012
• 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: 04/02/2021

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: REFER TO H10
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1