FDA Adverse Event Summary report: N

RX - WRITER

MDR report key: 8600479 · Received May 10, 2019

Report

Report Number
MW5086542
Date Received
May 10, 2019
Report Date
May 10, 2019
Manufacturer
NOVUS RX, LLC
Product Code
OUG
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

A (B)(6) PT RECEIVED 4 DOSES OF WRONG SILDENAFIL DOSE. HOME DOSE IS SILDENAFIL 5 MG/ML, GIVE 2 ML (10MG) EVERY 8 HOURS. UPON COMPLETING MEDICATION RECONCILIATION ON ADMISSION, SILDENAFIL ORDERED AS 10 MG/ML SOLUTION, GIVE 2 ML (20 MG) EVERY 8 HOURS. THE MEDICATION ERROR WAS DISCOVERED WHEN CALLING TO REFILL OUTPATIENT PRESCRIPTION FOR SILDENAFIL AND VERIFIED FORMULATION WITH OUTPATIENT PHARMACY. MEDICATION DOSE CHANGED TO SILDENAFIL 10 MG/ML, GIVE 1 ML (10 MG) EVERY 8 HOURS AFTER DISCOVERING MEDICATION ERROR. PT REMAINED HEMODYNAMICALLY STABLE. FAMILY NOTIFIED OF MEDICATION ERROR. EVENT INVESTIGATION: DIFFERENT CONCENTRATIONS, APPEARS ORDERED IN VOLUME (2 ML) VERSUS DOSE. SCM SHOWS MED ORDERED AS MG USING 10MG/ML, TO GIVE A VOLUME OF 2 ML. WHEN PROVIDER DID ADMISSION MED REC, BELIEVE THEY MUST HAVE ENTERED INTO OUTPATIENT MED REVIEW (OMR) AS 2 ML USING THE SCM OPTION OF CONCENTRATION OF 10 MG/ML (RX WRITER ISSUE/MULTUM ISSUE); PT TAKES 5 MG/ML CONCENTRATION; P&T APPROVED STD IS 2.5MG/ML. SINCE PT'S CONCENTRATION WAS NOT AVAILABLE IN RX WRITER, ORDER WAS COMPLETED WITH THE DOUBLE CONCENTRATION AND DIFFICULT TO TELL WHAT THEIR HOME DOSE WAS WHEN PHARMACIST VERIFIED. UNABLE TO REPLICATE IN SCM TEST BECAUSE THERE IS NO OPTION FOR 5MG/ML SUSPENSION; 10 MG/ML IS THE ONLY OPTION AND FORCED PROVIDER TO USE THIS INCORRECT CONCENTRATION. ISSUES: SCM, RX WRITER, MULTIPLE CONCENTRATIONS OF MEDS. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
391713 RX - WRITER MEDICAL DEVICE DATA SYSTEM OUG NOVUS RX, LLC

Patients

Seq Age Sex Outcome Treatment
1