FDA Adverse Event
Summary report: N
EPIC
MDR report key: 16487897
·
Received March 2, 2023
Report
- Report Number
- MW5115444
- Date Received
- March 2, 2023
- Report Date
- March 2, 2023
- Manufacturer
- EPIC SYSTEMS CORPORATION
- Product Code
- OUG
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- *
Narratives
Description of Event or Problem · 0
A PT HAD AN ORDER FOR VARENICLINE 0.5MG PO BID. HOWEVER, EPIC "DISPENSED" ONE-HALF 1MG TABLET RATHER THAN THE 0.5MG TABS THAT ARE AVAILABLE. IT WAS A NEAR MISS AS THE ERROR WAS IDENTIFIED BEFORE THE PT RECEIVED THE MEDICATION.(B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705927 | EPIC | MEDICAL DEVICE DATA SYSTEM | OUG | EPIC SYSTEMS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | VARENICLINE TARTRATE TAB ORAL 0.5MG | VARENICLINE TARTRATE TAB ORAL 1MG |