MAUDE Adverse Event Report: EPIC; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Device Problem Application Program Problem: Medication Error (3198)

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

Event Type  malfunction  

Event Description

Upon migration of medications to new ehr (eclinical works to epic), a patient had amlodipine/benazepril that was transferred over as amlodipine/atorvastatin.Patient was already on atorvastatin separately and ended up having a medication duplication within their chart.This was caught upon medication reconciliation.Education of staff to verify medication names and combination products were correct before implementation; changes to layout to show full name of medications for verification.Communication, poor / lacking (nonspecific) generic names look alike generic names look alike communication, poor / lacking (nonspecific).Special code: health info technology health info technology.Severity: error occurred; medication did not reach pt.(b)(6).Submission id: (b)(4).

Event Description

Additional information received for mw5104512 on 1/14/2022: manufacturer unknown.

• Brand Name: EPIC
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• MDR Report Key: 12615351
• MDR Text Key: 276395240
• Report Number: MW5104512
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2022
• Patient Sequence Number: 1
• Treatment: AMLODIPINE / ATORVASTATIN ; AMLODIPINE / BENAZEPRIL