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

Model Number RELEASES 2010.01 THROUGH 2015.01

Device Problems Computer Software Problem (1112); Device Issue (2379); Data Problem (3196); Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a priority review flash notification on december 31, 2015 to all potentially impacted client sites.The software notification includes a description of the issue, an alternative workflow, a method to identify data that might be affected by this issue, and notification that a software modification has been developed to address the issue fo all sites that could be potentially impacted.Cerner corporation considers the 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 corporation has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunctioned associated with this software product.Cerner's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for cerner registration management nor is it currently actively regulated by the fda.The issue involves cerner registration management in that when relationships are added to a person using the maintain relationships dialog box, information on the disease alerts list may not be copied from relationship type to another (opened from registration conversations) to add next of kin relationships to patients.Existing disease alerts may be removed for persons who are listed as next of kin and have an emergency contact relationships.Disease alerts are used to inform the staff of necessary infectious disease precautions to ensure staff safety and could potentially adversely affect patient safety as well.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: CERNER REGISTRATION MANAGEMENT
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rockcreek parkway; kansas city 64117
• Manufacturer (Section G): CERNER CORPORATION; 2800 rockcreek parkway; kansas city 64117
• Manufacturer Contact: shelley looby ; 2800 rockcreek parkway; kansas city 64117 ; 8162011368
• MDR Report Key: 5348053
• MDR Text Key: 35214612
• Report Number: 1931259-2016-00001
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/07/2016

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: RELEASES 2010.01 THROUGH 2015.01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2015
• Initial Date FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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