FDA Adverse Event Other Summary report: N

MAXORB AC PLUS 4X4.75

MDR report key: 5454932 · Received February 19, 2016

Report

Report Number
MW5060410
Event Type
Other
Date Received
February 19, 2016
Report Date
December 3, 2015
Manufacturer
ADVANCED MEDICAL SOLUTIONS
Product Code
FRO
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

DESCRIPTION: THE FACILITY RECEIVED A PRESCRIPTION FOR MAXORB AG PLUS 4X4.75. HOWEVER, THE PT DID NOT HAVE ORDERS FOR THIS MEDICATION. THE ORDERS WERE FOR A PT AT THE SAME FACILITY. INVESTIGATION RESULTS: AFTER REVIEW OF THE ABOVE ISSUES, THE FOLLOWING WAS DETERMINED. TYPE OF MEDICATION ERROR: INCORRECT PT. WAS THE MEDICATION ADMINISTERED TO THE RESIDENT: NO. AREA WHERE ERROR OCCURRED: DATA ENTRY. INITIAL REVIEW MEDICATION(S)/PRODUCT(S) INVOLVED: MAXORB AG PLUS 4X4.75. ORDER ERROR POTENTIAL: HIGH. ROOT CAUSE: MULTIPLE PT ORDERS WERE SUBMITTED ON ONE SHEET FROM THE FACILITY. THE DATA ENTRY TECH DEVIATED FROM ESTABLISHED POLICY AND PROCEDURE BY NOT VERIFYING TWO POINTS OF IDENTIFICATION. TWO POINTS OF IDENTIFICATION WERE PRESENT ON THE ORDER. THE PHARMACIST DEVIATED FROM ESTABLISHED POLICY, AND PROCEDURE AND APPROVED THE ORDER AS CORRECT. (B)(6). MEDICATION ADMINISTERED TO OR USED BY THE PT: NO. WHERE DID THE ERROR OCCUR: LONG TERM CARE FACILITY. TYPE OF STAFF MADE INITIAL ERROR: PHARMACY TECH. WERE OTHER PRACTITIONER(S) INVOLVED (PERPETUATE) IN THE ERROR: YES, PHARMACIST. SEVERITY: ERROR REACHED PT; NO PT HARM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
105488 MAXORB AC PLUS 4X4.75 MAXORB AC PLUS 4X4.75 FRO ADVANCED MEDICAL SOLUTIONS

Patients

Seq Age Sex Outcome Treatment
1