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

Model Number MERGE LIS V 4.1.6

Device Problem Output Problem (3005)

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

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

An internal investigation was performed based on the customer's allegation.Merge healthcare determined that there is a deficiency in the software and this confirmed the customer's allegation.Should an lis user delete a test from the uncollected containers dashboard, the entire order may be deleted.It has been determined that modifications to the software should occur to mitigate this issue and to ensure that only intended tests are cancelled from a patient order.Modifications to the software will be made to correct this issue in an upcoming merge lis software release.It should be noted that though merge lis allows orders to be edited from the uncollected containers dashboard, the more common workflow in merge is to delete tests directly from the order entry/accession tab and this workflow is working as designed.If a user deletes a test from an order in the order entry/accession tab, the test is deleted as expected and not the entire order.

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) 2017 the customer reported that when deleting one test off an order in merge lis, the whole order was deleted in merge.Customer indicated this issue has occurred twice.Merge healthcare investigated the customer's workflow process.The customer places orders in their emr which cross to merge lis with a status of "e" (entered) and drops to the uncollected containers dashboard under the specimen handling tab.In uncollected containers dashboard, the user has the ability to edit an order.To edit the order, the user selects "edit order" button from uncollected containers dashboard.This takes the user to the accession tab of order entry.User selects the test they wish to delete and saves.When save is selected, merge lis prompts the user for a delete comment.Afterwards, when the user searches for the patient in uncollected containers dashboard or order entry, the whole order is deleted and not just the single test.With merge lis deleting an entire order instead of a single test, there is a potential for a delay in treatment and/or diagnosis which could lead to harm to a patient; however, there is no indication that the issue, reported by the customer, resulted in a death or serious injury reference complaint number (b)(4).

Manufacturer Narrative

Merge healthcare investigated the issue and determined that there was a deficiency in the software when deleting a test from an order in the uncollected containers dashboard.A deficiency in the code was improperly deleting the whole order when the user intended to delete an individual test.Code modifications were implemented to properly manage the deletion of a test.If a test is deleted for an accession using the uncollected containers dashboard, if the order includes other tests, only the selected test will be deleted and not the entire order.It should be noted that merge lis allows tests to be deleted directly from the order entry/accession tab and this workflow was always working as designed.If a user deletes a test from an order in the order entry/accession tab, the test is deleted as expected and not the entire order.Most users of merge lis use the orderentry/accession screen to delete a test from an order, instead of going through the uncollected dashboards screen.This is a basic function of merge lis and should be familiar to all trained users.Only a small number of lis customers use uncollected dashboards as this functionality is typically reserved for future orders or multi-site labs.The customer was able to edit orders directly from the order/entry accession tab.The code deficiency was corrected 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 (b)(6).Revised information contained in this supplement report includes the following: d3: updated manufacturer contact name.G1-2: updated office contact name.G4: date new information received by manufacturer (corrected software release date).G7: indication that this is follow-up report 001.H1: indicated that type of reportable event is a malfunction.H2: indication that the follow-up type is additional information.H10: indication that additional manufacturer information is contained in this follow-up report.

• 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: 6459380
• MDR Text Key: 71729012
• Report Number: 2183926-2017-00083
• 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: 03/06/2017

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 4.1.6
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1