MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM ANATOMIC PATHOLOGY; SOFTWARE

Model Number 2007.19 THROUGH 2018.01

Device Problem Computer Software Problem (1112)

Patient Problems No Code Available (3191); Missing Value Reason (3192)

Event Date 01/11/2010

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on april 6, 2018 to all potentially impacted client sites.The software notification includes a description of the issue and explains that a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner corporation will provide a follow-up report when the software modification is available.

Event Description

This report documents information related to an issue identified with functionality included in cerner's millennium anatomic pathology; class i, product code jqp.This issue involves cerner millennium anatomic pathology and occurs when an order is placed for a patient using an anatomic pathology orderable item that has an order comment associated with a julian accession number.If this order is added to an existing open case for the same patient, the order comment associated with the julian accession number is not displayed.This issue could result in a pathologist processing specimens without knowledge of the associated order comments.Cerner received a report that, due to the order comments not being available, an incomplete report was generated and the pathologist processed specimens without knowledge of the associated order comments.

Event Description

This report documents information related to an issue identified with functionality included in cerner's millennium anatomic pathology; class i, product code jqp.This issue involves cerner millennium anatomic pathology and occurs when an order is placed for a patient using an anatomic pathology orderable item that has an order comment associated with a julian accession number.If this order is added to an existing open case for the same patient, the order comment associated with the julian accession number is not displayed.This issue could result in a pathologist processing specimens without knowledge of the associated order comments.Cerner received a report that, due to the order comments not being available, an incomplete report was generated and the pathologist processed specimens without knowledge of the associated order comments.

Manufacturer Narrative

Cerner distributed a flash notification on april 6, 2018 to all potentially impacted client sites.The software notification includes a description of the issue and explains that 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 14, 2018 to communicate 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.

• Brand Name: CERNER MILLENNIUM ANATOMIC PATHOLOGY
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 7427171
• MDR Text Key: 105676879
• Report Number: 1931259-2018-00005
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2007.19 THROUGH 2018.01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 01/11/2010
• Supplement Dates FDA Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1