MAUDE Adverse Event Report: CERNER CORPORATION FOREIGN SYSTEMS INTERFACES; SOFTWARE

Model Number 2018.03+

Device Problem Computer Software Problem (1112)

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

Event Date 03/31/2023

Event Type  malfunction  

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 systems interface, nor are these products currently actively regulated by the fda this issue involved the cerner foreign systems interface to a third party systems that provides order checking (i.E., drug interactions, drug allergy) when ordering medications.There is an issue in the interface scripting that caused an incorrect identifier to be transmitted in a message from cerner to the third party system.This impact results in incorrect order checking for prescriptions.This issue could result in medications that are not appropriate for the patient.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner directly notified the potentially impacted clients on (b)(6) 2023.The software notification includes a description of the issue and a scripting modification that was completed on (b)(6) 2023.

• Brand Name: FOREIGN SYSTEMS INTERFACES
• 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: jeff mauzey ; 8779 hillcrest road; kansas city, MO 64138 ; 8162010605
• MDR Report Key: 16791849
• MDR Text Key: 313825755
• Report Number: 1931259-2023-00007
• 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: 04/21/2023

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: 2018.03+
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2020
• 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