MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM EPRESCRIBING HUB, POWERORDERS AND PLANS; SOFTWARE

Model Number 2021.11

Device Problem Computer Software Problem (1112)

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

Event Date 12/20/2021

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 millennium power orders® and power plans® 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 power orders® and power plans® eprescribe¿ hub functionality.The issue impacts users who send prescriptions electronically to pharmacies from the cerner eprescribing hub between (b)(6) 2021.New prescriptions submitted electronically may not be routed to pharmacies if the prescription order contains a real time prescription benefits (rtpb) response id with the prefix cmm.The status for these messages is displayed as delivered to pharmacy and the system does not notify the ordering physician that the prescription was not successfully sent.Patient care may be affected if a prescription does not reach the intended pharmacy and patients are unable to take their medication as prescribed.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) 2021 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.

• Brand Name: CERNER MILLENNIUM EPRESCRIBING HUB, POWERORDERS AND PLANS
• 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: shelley looby ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 13089878
• MDR Text Key: 290160786
• Report Number: 1931259-2021-00021
• 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: Notification
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2021.11
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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