FDA Adverse Event Other Summary report: N

EPIC

MDR report key: 6157633 · Received December 6, 2016

Report

Report Number
MW5066600
Event Type
Other
Date Received
December 6, 2016
Report Date
September 6, 2016
Manufacturer
EPIC SYSTEMS CORPORATION
Product Code
MMH
Report Source
Voluntary report
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

THE CPOE SYSTEM, EPIC, IS ONE OF THE LARGEST IN THE UNITED STATES. EPIC HAS AN INHERENT PROBLEM: ORDERS FOR MEDICATION SHOW UP IN THE MEDICATION ADMINISTRATION CHARTING (MAR) SECTION IN AN ERRONEOUS, AND, I BELIEVE, CONFUSING AND POSSIBLE DANGEROUS MANNER. THE MAR, AND THE LABEL THAT ISSUES FROM THE PRINTER IN EPIC, CONFUSES PRODUCT STRENGTH WITH DOSE. FOR EXAMPLE, A 3 MG DAILY DOSE OF SIROLIMUS APPEARS AS "SIROLIMUS TABLET 3 MG; DOSE 3 MG ORAL DAILY. SIROLIMUS IS NOT MARKETED IN A 3 MG TABLET. SIMILARLY, ANY DOSE OF A PRODUCT THAT DOES NOT EXACTLY MATCH THE TABLET STRENGTH APPEARS IN THE SAME CONFUSING PATTERN: E.G., A DOSE OF MESALAMINE CAPSULES 1600 MG APPEARS AS "MESALAMINE CAPSULE 1600 MG DOSE 1600 MG ETC." MESALAMINE IS NOT MARKETED AS A 1600 MG CAPSULE. THE ABOVE SHOULD READ, CORRECTLY, IN THE MAR (AND ON LABELS) AS: SIROLIMUS TABLET (OR TABLETS) 1 MG, DOSE 3 MG, AND MESALAMINE CAPSULE (OR CAPSULES) 400 MG, DOSE 1600 MG, ETC. THIS INHERENT SOFTWARE ERROR HAS WIDESPREAD DISTRIBUTION, I BELIEVE, AND SHOULD BE RECTIFIED. MY ATTEMPTS TO POINT OUT THIS PROBLEM HAVE BEEN IGNORED LOCALLY. SEVERITY: CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
797726 EPIC MEDICAL COMPUTER AND SOFTWARE MMH EPIC SYSTEMS CORPORATION

Patients

Seq Age Sex Outcome Treatment
1