MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE LIS; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number MERGE LIS V 4.1.5 PATCH 1

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

An internal investigation was performed based on the customer's allegation and the past medications checkbox is functioning as designed.Selecting a past medication is working as intended as past medications associated to an accession are displayed to the user.However, the process for utilizing the past medications tool is not intuitive to users and is not functioning as users expect based on toxicology workflow.When a user selects a medication from the past medications list they mistakenly believe they are adding the medication to the current medication list.This belief is enforced with the past medication displaying in the worklist.When toxicology customer's review results on a patient in the worklist , they utilized the medication box to make decisions on whether the flagging of consistent (c) and/or inconsistent (i) is accurate.Merge healthcare is in the process of determining what modifications to the software should occur to mitigate this issue and clearly define the function of a past medication list to meet the workflow needs of toxicology users.A supplemental report will be submitted following merge healthcare's investigation.It should be noted that during order entry, lis toxicology users can add medications on the accession and generate the correct flagging without the use of the past medications list.

Event Description

Merge lis is intended to be used for receiving, viewing, communicating and storing results from laboratory modalities.Lis functionality includes, recording, annotating, creating/printing labels, calculations, patient medication/interaction information, monitoring, reporting and trending of patient lab results.On (b)(6) 2016 a toxicology customer reported that a medication selected from the past medications list was flagging incorrectly as inconsistent (i).During order entry, the customer added current medications to a patient accession.The customer also tried to add a past medication to the current order by selecting a medication from the past medications list.On the worklist both current and past medications displayed in the medication list; however, the workflow did not add the past medication to the accession as a current medication as the customer expected.When verifying test results, the current medications flagged correctly; however, the selected past medication did not flag as expected.Merge healthcare investigated the issue and determined merge lis functions correctly when following the workflow process as designed.Inaccurate lab results reported or associated with a patient could lead to an incorrect diagnostic evaluation resulting in an unnecessary procedure or inappropriate treatment; however, the customer was performing testing within their test environment, not a live environment, and there is no indication that the issue, reported by the customer, resulted in a death or serious injury.(b)(4).

Manufacturer Narrative

Merge healthcare corrected a design deficiency in which the past medications tool was not intuitive to toxicology users and was not functioning as users expected based on toxicology workflow.This design was not anticipated to be a source of confusion for users.Changes were made to the medication screen layout to clearly define the function of the past medication list and eliminate the potential for inaccurate flagging.Past medications will not be allowed to be associated to new accessions.The layout changes were documented in the merge lis v.4.2 user manual, chapter 2 order entry, meds tab section.Issue was resolved in merge lis software version 4.2 released july 9, 2018.Merge lis v.4.2 release notes documents that this issue is resolved under release 4.2, resolved issues section, id lis-5425.Proper toxicology workflow practice during order entry is to add medications on the accession and generate the correct flagging without the use of the past medications list.Revised information contained in this supplement report includes the following: g7: indication that this is follow-up report 001.

• Brand Name: MERGE LIS
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut rigde drive; hartland WI 53029
• MDR Report Key: 5972240
• MDR Text Key: 55443756
• Report Number: 2183926-2016-00711
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE LIS V 4.1.5 PATCH 1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/22/2016
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1