MAUDE Adverse Event Report: CERNER CORPORATION MILLENNIUM DATABASE ARCHITECTURE; SOFTWARE

Model Number ADMINISTRATION.173 AND ADMINISTRATION.174

Device Problem Computer Software Problem (1112)

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

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on october 28, 2022 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® database architecture 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® database architecture.This issue occurs when a client installs millennium database architecture which causes an error to occur during combining patient and encounter records.This error causes the combine process to fail and prevents person or encounter records from being combined.Patient care may be affected if a patient has multiple active person or encounter records that cannot be combined.If the clinician is not aware of or have access to the multiple records, clinical care decisions could be made based on incomplete information.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: MILLENNIUM DATABASE ARCHITECTURE
• 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 ; 8162011386
• MDR Report Key: 15691702
• MDR Text Key: 306800587
• Report Number: 1931259-2022-00010
• 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: Modification/Adjustment
• Type of Report: Initial
• Report Date: 10/28/2022

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: ADMINISTRATION.173 AND ADMINISTRATION.174
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• 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