MAUDE Adverse Event Report: EMR; MEDICAL DEVICE DATA SYSTEM

Device Problem Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Description

I am reporting a series of events related to the use of vancomycin.My institution uses precision dosing software to calculate optimal vancomycin doses.This software is not integrated or interfaced with the emr.It requires manual data entry (entering labs, medication doses, demographic information) in order to calculate doses.In a review of 86 patient courses, data entry errors occurred 17% (15).This resulted in 3% (3) of patients receiving inappropriate doses.There was no clear harm to the patient as a result of these errors.(b)(4).

• Brand Name: EMR
• Type of Device: MEDICAL DEVICE DATA SYSTEM
• MDR Report Key: 12908711
• MDR Text Key: 281739999
• Report Number: MW5105691
• Device Sequence Number: 3
• Product Code: LRJ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/03/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1