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

Model Number 2007.19-2018.01

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on october 1, 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 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®.The issue involves cerner millennium registration management and occurs when users add a subscriber relationship of self to a patient that was registered in a different time zone.The patient's birth date and birth times displayed in the patient chart may be offset by the number of hours between the two time zones.Patient care could be adversely affected if treatment decisions are based on incorrect time of birth for an infant.Patient care could also be delayed if a user searches for patients by birth date and, if the patient cannot be located, create a duplicate record for the patient.Cerner has not received communication on any 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
• Manufacturer (Section G): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• Manufacturer Contact: shelley looby ; 2800 rock creek parkway; kansas city, MO 64117 ; 8162011368
• MDR Report Key: 7939948
• MDR Text Key: 123958560
• Report Number: 1931259-2018-00011
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2007.19-2018.01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2009
• 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