MAUDE Adverse Event Report: ECLINICALWORKS ECLINICALWORKS; MEDICAL COMPUTERS AND SOFTWARE

Device Problems Computer Software Problem (1112); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

We reported a new issue with eclinicalworks with the newest version 11 on (b)(6) related to prescriptions.The issue occurs when a decimal point is typed in a dosage.For example, if a provider is prescribing 2.5 ml twice a day, when the dose is typed, the decimal point is immediately removed by the software.If this is not noticed by the provider who is typing in the dose, it could result in a 10 fold or even 100 fold dosing error in the case of something like 1.25 ml.This could be potentially fatal depending on the medication being prescribed if it is not detected.We entered the case on (b)(6) and to date there has been no solution offered and the issue still exists, leaving the door open for potentially severe pt safety concerns.

• Brand Name: ECLINICALWORKS
• Type of Device: MEDICAL COMPUTERS AND SOFTWARE
• Manufacturer (Section D): ECLINICALWORKS; 2 technology dr.; westborough MA 01581
• MDR Report Key: 7457694
• MDR Text Key: 106703658
• Report Number: MW5076691
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other