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 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

An internal investigation was performed.Merge healthcare determined there is a deficiency in the software which allows toxicology user's to configure screening tests on the summary of findings (sof) report.The software does not exclude screening tests from appearing in the sof configuration.Since flagging in merge lis is not dependent on the screening test, incorrect flagging may occur against the screening result.To reduce user error with configuring toxicology screening tests on the sof report, the merge lis v.4.1.4, revision 5.0, administration manual, chapter 6 coded dictionary maintenance > summary of findings setup > was updated on page 85 with the following : "note: screening tests should not be selected for the summary of findings report." the update was implemented on 01/05/2017.Additionally, to help mitigate the issue, merge lis v.4.1.6, revision 2.0, release notes were updated on 01/10/2017 to include the toxicology screen configuration issue in the list of known issues and workarounds.The following synopsis was added on page 21, under id lis-5928 "if toxicology screening results are included in coded dictionary maintenance > site definition > summary of findings setup, the report may display those results incorrectly.Workaround: do not include screening tests on the summary of findings report." merge healthcare determined modifications to the lis software are necessary to further mitigate this issue and ensure screening tests cannot be configured to appear on the sof report and will be implemented in a future software release.

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, a toxicology customer reported a toxicology screen result was not flagging correctly on their summary of findings (sof) report.The positive drug screen result incorrectly flagged as inconsistent instead of consistent for the prescribed medication.Merge lis does not support toxicology screen results on the summary of finding (sof) report.The sof is designed for use with a drug confirmation panel; however, merge healthcare determined during the investigation that there is a deficiency in the software which allows users to configure toxicology screening tests to appear on the sof report.Since flagging in merge lis is not dependent on the screening test, incorrect flagging may occur against the screening result.The summary of findings is an optional report that can be appended to the final patient report and is utilized by some doctors or sites as a tool for summarizing significant cutoff or validity results.No issue was identified with the reporting and flagging of results on the final patient report.Merge healthcare assisted the customer by correcting the toxicology screen configuration on the customer's environment, thus removing the screening test from appearing on the sof report.Incorrect flagging associated with a patient result could lead to a delay in treatment; however, there is no indication that the issue, reported by the customer, resulted in a death or serious injury.(b)(4).

• Brand Name: MERGE LIS
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6632864
• MDR Text Key: 77543045
• Report Number: 2183926-2017-00121
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2017

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: 05/12/2017
• Initial Date FDA Received: 06/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1