MAUDE Adverse Event Report: CERNER CORPORATION DISCERN EXPLORER, ENTERPRISE MASTER PERSON INDEX, FSI, REGISTRATION MANAGEMENT; SOFTWARE

Model Number 2018.01, 2018.01.07, 2018.01.08

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on june 26, 2019 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 discern explorer®, enterprise master person index®, foreign system interfaces®, 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 discern explorer®, enterprise master person index®, foreign system interfaces®, registration management®.The issue occurs with a particular release level of cerner millennium that also contains an updated version of cerner's scripting language, which is used for application services for inbound hl7 interface processing.Further, it only occurs if the parameters used to configure the matching of inbound hl7 interface transactions to patient medical records have all weighted values equal to zero in the same production environment when cerner millennium is set up to receive inbound hl7 transactions and is configured to perform probabilistic person reconcile automatically for a contributor system.The system may inadvertently use probabilistic matching in addition to using deterministic matching which causes patient records that have a low probability of being a match to be incorrectly combined.At this point, cerner is aware of this issue having materialized in only one client environment.In-depth mitigation efforts have been carried out in that instance, and a thorough review of our client base shows that the conditions under which the issue would occur are not present in any other environments.Cerner received a report of a near-miss where clinicians noted a blood group and type discrepancy in the chart of a patient scheduled for surgery.No report of patient harm has been received by cerner.

• Brand Name: DISCERN EXPLORER, ENTERPRISE MASTER PERSON INDEX, FSI, 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: 8759502
• MDR Text Key: 209175898
• Report Number: 1931259-2019-00002
• 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: 07/03/2019

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: 2018.01, 2018.01.07, 2018.01.08
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2019
• 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