FDA Adverse Event
Summary report: N
EPIC
MDR report key: 8206425
·
Received December 28, 2018
Report
- Report Number
- MW5082699
- Date Received
- December 28, 2018
- Report Date
- December 28, 2018
- Manufacturer
- EPIC SYSTEMS CORPORATION
- Product Code
- OUG
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
NEAR MISS. A PHARMACIST WAS VERIFYING RHO D IMMUNE GLOBULIN(WINRHO) AND NOTICED THAT THE DOSE DRAWN UP FROM THE VIALS DID NOT MATCH THE ORDERED DOSE. THE DOSE PULLED UP WAS 4,000 UNITS RATHER THAN 4,000 MCG. UPON INVESTIGATION IT WAS DISCOVERED THAT WINRHO IS DOSED IN MCG, BUT WHEN ORDERED FROM CARDINAL, IT IS LISTED AS UNITS. ALSO, EPIC ONLY LISTS THE UNITS IN THE PRODUCT INFORMATION. THIS RESULTED IN US ORDERING AN INCORRECT DOSE FROM CARDINAL AND NEARLY GIVING THE PATIENT A QUARTER OF THE DOSE THAT THEY NEED FOR THEIR SEVERE ITP. CARDINAL HAS BEEN CONTACTED AND THEY ARE WORKING TO ADD THE MCGS IN THE PRODUCT DESCRIPTION. WE ARE ALSO LOOKING INTO CHANGING HOW THIS MEDICATION IS DISPLAYED IN EPIC. (B)(6). ACCESS NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1044302 | EPIC | MEDICAL DEVICE DATA SYSTEM | OUG | EPIC SYSTEMS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |