MAUDE Adverse Event Report: CERNER CORPORATION FOREIGN SYSTEM INTERFACES

Model Number 2018.01.10-2018.15

Device Problem Computer Software Problem (1112)

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on april 21, 2023, 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.

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 foreign system interfaces 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 foreign system interfaces outbound results.The issue involves cerner millennium foreign system interfaces and affects users that utilize the outbound results to populate discrete task assay results which includes both free-text and coded results.In cerner millennium, when stand-alone discrete result grouping is configured for the foreign system interface to allow free-text result values for discrete events and discrete task assays (dta) and discrete results are entered as free text and the system generates an outbound hl7 message, the system does not match the correct discrete result value for the free-text dta.As a result, the system will transmit the incorrect results when generating hl7 messages to third party systems.Patient care could be adversely affected, as clinicians access and use incorrect data.This issue could result in non-serious injury and could impact the care delivery system.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on (b)(6) 2023, 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 an updated flash notification on august 10, 2023 to all potentially impacted client sites.The software notification includes a description of the issue andm that 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 foreign system interfaces 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 foreign system interfaces outbound results.The issue involves cerner millennium foreign system interfaces and affects users that utilize the outbound results to populate discrete task assay results which includes both free-text and coded results.In cerner millennium, when stand-alone discrete result grouping is configured for the foreign system interface to allow free-text result values for discrete events and discrete task assays (dta) and discrete results are entered as free text and the system generates an outbound hl7 message, the system does not match the correct discrete result value for the free-text dta.As a result, the system will transmit the incorrect results when generating hl7 messages to third party systems.Patient care could be adversely affected, as clinicians access and use incorrect data.This issue could result in non-serious injury and could impact the care delivery system.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: FOREIGN SYSTEM INTERFACES
• Type of Device: FOREIGN SYSTEM INTERFACES
• 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: jeff mauzey ; 8779 hillcrest road; kansas city, MO 64138 ; 8162010605
• MDR Report Key: 16935318
• MDR Text Key: 315411990
• Report Number: 1931259-2023-00012
• 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,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2018.01.10-2018.15
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• 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