MAUDE Adverse Event Report: CERNER CORPORATION CERNER RETAIL PHARMACY; SOFTWARE

Model Number ALL RELEASES

Device Problems Device Alarm System (1012); Computer Software Problem (1112)

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) distributed a priority review flash notification on march 16, 2016 to all potentially impacted client sites.The software notification includes a description of the issue, an alternate workflow, and notification 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

When a multiple-ingredient medication is dispensed through the cerner retail pharmacy solution, it will not check all of the ingredients against a patient's medication history for possible duplicate therapies.Therefore, an alert is not displayed when the patient has an active prescription for a medication containing an ingredient that is also in the multiple-ingredient medication.This could result in a patient taking more of a medication than was prescribed.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

(b)(4) distributed a priority review flash notification on march 16, 2016 to all potentially impacted client sites.The software notification includes a description of the issue, an alternate workflow, and notification that a software modification is being developed to address the issue for all sites that could be potentially impacted.(b)(4) distributed a follow-up priority review flash notification on june 28, 2016 to all potentially impacted client sites.The software notification includes a description of the issue and notification that a software modification has been developed to address the issue for all sites that could be potentially impacted.(b)(4) 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 (b)(4) has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.(b)(4) filing of this medwatch report does not signify (b)(4) belief or understanding that medical device reports are required to be filed for (b)(4) nor is it currently actively regulated by the fda.When a multiple-ingredient medication is dispensed through the (b)(4) solution, it will not check all of the ingredients against a patient's medication history for possible duplicate therapies.Therefore, an alert is not displayed when the patient has an active prescription for a medication containing an ingredient that is also in the multiple-ingredient medication.This could result in a patient taking more of a medication than was prescribed.(b)(4) has not received communication on any adverse patient events as a result of this issue.

• Brand Name: CERNER RETAIL PHARMACY
• 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: 5510499
• MDR Text Key: 40677969
• Report Number: 1931259-2016-00005
• 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: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Pharmacist
• Device Model Number: ALL RELEASES
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2008
• 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