MAUDE Adverse Event Report: MEDICAL COMPUTERS AND SOFTWARE

Device Problem Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

Patient has been taking tozal, an omega 3 based dietary supplement, instead of rheumate, a b-vitamin supplement from xx-x-2017 until x-xx-2017 (5 months after).We filled tozal as a substitute for the rheumate.The tozal was listed as a substitute for the rheumate in our computer system.The prescriber caught the error and informed the patient.She informed us on x-xx-2017.We immediately removed the option to select tozal as equivalent in our computer system and contacted the software vendor to let them know.They will be checking their system to ensure this med error was an isolated incident within our system.(b)(6).(b)(4).Medication administered to or used by the patient: no.Relevant materials provided: none.

• Brand Name: MEDICAL COMPUTERS AND SOFTWARE
• Type of Device: MEDICAL COMPUTERS AND SOFTWARE
• MDR Report Key: 8389839
• MDR Text Key: 137949334
• Report Number: MW5084626
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1