EPIC SOFTWARE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-25 for EPIC SOFTWARE manufactured by Epic.

Event Text Entries

[41557576] My health care provider uses epic software to send prescriptions to the pharmacy. The provider submitted 9 vials of novalog for 90 days, but what was received at the pharmacy was 6 vials of humalog for 60 days. I have had this occur twice in the past 18 months with a different health care provider and different pharmacy. Something is wrong with the file once it leaves through epic software's ehr gateway and is received by the pharmacies. I would have received the wrong insulin and would not have had enough insulin for the 90 days that is required by my health insurance. I believe epic software is regulated as a medical device because it provides drop downs for medications and their uses. If not it should be regulated the same as other medical device software. I did not pick up the prescription. I had the doctor send it again to third pharmacy. I have not attempted to fill yet.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5061317
MDR Report Key	5535111
Date Received	2016-03-25
Date of Report	2016-03-25
Date of Event	2016-03-23
Date Added to Maude	2016-03-30
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
Reporter Occupation	PATIENT
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	EPIC SOFTWARE
Generic Name	EPIC SOFTWARE
Product Code	NSX
Date Received	2016-03-25
Device Availability	N
Device Eval'ed by Mfgr	*
Device Sequence No	1
Device Event Key	0
Manufacturer	EPIC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-03-25