MAUDE Adverse Event Report: CERNER CORPORATION MPAGES; SOFTWARE

Model Number MPAGES 6.16 THROUGH MPAGES 7.3.2

Device Problem Computer Software Problem (1112)

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

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a 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®, 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 ® workflow labs flowsheet grouping component.The issue involves cerner millennium mpages and affects users that view laboratory results in the workflow labs flowsheet grouping component.This issue can cause rows of results to become misaligned with the result name in the table view when there are 50 or more results.The more results that are present, the more offset each row becomes.This issue only affects the visual display of data in the table.The details are correctly displayed in the detail pane.Patient care could be adversely affected if clinical decisions are based on a result that is misaligned to the result name.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: MPAGES
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer (Section G): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer Contact: shelley looby ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 12366819
• MDR Text Key: 268112845
• Report Number: 1931259-2021-00015
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPAGES 6.16 THROUGH MPAGES 7.3.2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1