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

Model Number MERGE LIS V 4.1.5

Device Problems Device Issue (2379); Output Problem (3005)

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

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

An internal investigation has been completed based on the customer's allegation.Merge healthcare determined that there was a deficiency in the software and this confirmed the customer's allegation.Should an lis user add tests but not add in all the elements, specifically billing codes, there is a potential that results may not be sent to an emr system.It has been determined that modifications to the software should be used to mitigate this issue and to ensure that results are sent even when billing codes may not be entered by users.It should be noted that lis users can use a workaround where a user prints/saves/sends the results from the modality to required recipients directly, without the use of lis.Lis users also have an error log/notification that provides information regarding the failure of results not being sent to an emr system due to missing billing codes.

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 & trending of patient lab results.On (b)(6) 2016 the customer reported a patient result was not being sent automatically to their hospital interface on the interim report.Merge healthcare support investigated the issue and determined that one of the results was missing a loinc (insurance billing codes) code and that prevented the report transmission.Merge support assisted the customer and the missing loinc codes were entered into the system for the results.Once added, the results transmitted as expected to the emr system.With merge lis not sending results as expected, there is a potential for a delay in treatment or diagnosis which could lead to harm.However, there is no indication that the issue, reported by the customer, resulted in a death or serious injury.(b)(4).

Manufacturer Narrative

Merge healthcare determined there was a deficiency in the merge lis software with results not crossing from merge lis to the customer's results interface when the loinc (insurance billing code) cross reference was enabled for the billing interface.Should an lis user add tests but not add in all the elements, specifically billing codes, there is a potential that results may not be sent to the results interface.Merge lis users can refer to an error log/notification that provides information regarding the failure of results not being sent to the results interface due to missing billing codes; however, to further mitigate this issue, modifications to the software were made in the upcoming lis version 4.2 software release, in which a visual alert will notify users if a result is missing a loinc so users can add the loinc to avoid any delay in results crossing to the results interface.

• 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: 5835479
• MDR Text Key: 50816321
• Report Number: 2183926-2016-00663
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/30/2016
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1