EMR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-26 for EMR manufactured by Epic.

Event Text Entries

[90519940] I wanted to let you know that we recently noticed a change in electronic prescriptions sent to the pharmacy from the emr that once contained the name brand and generic name of the drug in the drug name field to just sending the generic name only on all prescriptions. I contacted our emr (epic) who mentioned surescripts made a switch around (b)(6). This could cause med errors. Our pharmacy software vendor (qs/1) had also taken the following pharmacy examples to launch an investigation claim for surescripts but no progress seems to have been made. For example: script now comes to the pharmacy as insulin glargine pen and the pharmacy does not know if the prescription is for lantus solostar or basaglar; script now comes to the pharmacy as metformin extended release tablets and the pharmacy does not know if the prescription is for fortamet or glucophage xr; script for trulicity now comes over as the generic name and a generic isn't even available. These are just a few examples we encountered on the first day of the switch. Every prescription now only shows then generic name only. (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5072946
• MDR Report Key: 6979141
• Date Received: 2017-10-26
• Date of Report: 2017-08-25
• Date Added to Maude: 2017-10-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: EMR
• Generic Name: SOFTWARE, TRANSMISSION AND STORAGE, PATIENT DATA
• Product Code: NSX
• Date Received: 2017-10-26
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EPIC

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-10-26