MAUDE Adverse Event Report: CERNER CORPORATION CERNER CUSTOM SOFTWARE SCRIPT

Device Problem Installation-Related Problem (2965)

Patient Problem No Information (3190)

Event Date 04/30/2015

Event Type  malfunction  

Event Description

The issue involves the products listed above and occurs when encounter-organization security is defined for users that could limit the medications that would be included in the patient summary medication list.This summary is given to patients upon discharge and would be expected to include any physician instructions as well as a complete list of medications the patient should be taking once discharged.If the user does not have the proper privileges defined in encounter-organization security, the medication list would be limited to those that the user has access to.The patient may not be provided a complete list of medications which could result in the patient not taking necessary medications to continue treatment after discharge.This was limited to one client site and no other clients are impacted.Cerner has received communication that one patient was readmitted to the hospital due to not taking the correct medications.

Manufacturer Narrative

Cerner distributed a priority review flash notification on 06/02/2015 to all potentially impacted client sites.The notification includes the reminder that when encounter-organization security is enabled, any customer script with encounter-organization security logic mimics the system's encounter-organization security configuration.If the custom script does not follow the cerner standard for encounter-organization security, the system could incorrectly restrict or grant access to patient data.Cerner corporation will provide a follow-up report when the software modification is available.

Manufacturer Narrative

Cerner distributed a priority review flash notification on (b)(6) 2015 to all potentially impacted client sites.The notification includes the reminder that when encounter-organization security is enabled, any custom script with encounter-organization security logic mimics the system's encounter-organization security configuration.If the custom script does not follow the cerner standard for encounter-organization security, the system could incorrectly restrict or grant access to patient data.The client verified that their configuration had been corrected and the issue was no longer occurring on (b)(6) 2015.The client has notified all patients potentially impacted by this issue.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 malfunction 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 products utilizing custom scripts nor are these currently actively regulated by the fda.This report documents information related to an issue identified within a custom script containing encounter-organization security logic.The issue involves the products listed above and occurs when encounter-organization security is defined for users that could limit the medications that would be included in the patient summary medication list.This summary is given to patients upon discharge and would be expected to include any physician instructions as well as a complete list of medications the patient should be taking once discharged.If the user does not have the proper privileges defined in encounter-organization security, the medication list would be limited to those that the user has access to.The patient may not be provided a complete list of medications which could result in the patient not taking necessary medications to continue treatment after discharge.This was limited to one client site and no other clients are impacted.Cerner has received communication that one patient was readmitted to the hospital due to not taking the correct medications.

• Brand Name: CERNER CUSTOM SOFTWARE SCRIPT
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• Manufacturer (Section G): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• Manufacturer Contact: shelley looby ; 2800 rockcreek parkway; kansas city, MO 64117 ; 8162011368
• MDR Report Key: 4821600
• MDR Text Key: 5843007
• Report Number: 1931259-2015-00004
• 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,company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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
• Patient Outcome(s): Hospitalization