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 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

During the investigation it was identified that the customer verified toxicology results prior to completing the validity test on the sample.When the validity test was rejected, verified drug tests were then cancelled.Due to the customer's incorrect workflow, when the patient results were reported, the summary of findings (sof) report incorrectly reported verified toxicology test results that had been cancelled.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 of results on the final patient report.When the final patient report is generated the report does not contain the cancelled toxicology results.Merge healthcare determined modifications to the lis software are necessary to mitigate this issue and ensure that when a toxicology test is cancelled, none of the associated results appear on the sof report.The modifications will be implemented in a future software release.Actions indicate this is a user error due to the customer not following proper workflow practice when performing their validity/toxicology testing.

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 that the summary of findings (sof) report was displaying deleted test results.Merge healthcare investigated the customer's workflow practice.The customer performs validity testing on samples that are received for toxicology testing to help ensure the integrity of the sample.Proper workflow practice dictates validity testing on samples be performed prior to performing drug testing.In this instance, some drug testing results were verified prior to the validity testing being completed.When the validity test was completed, the results for the validity test were rejected and consequently, verified drug tests were cancelled.When the patient results were reported, the sof report displayed results for cancelled toxicology tests.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, 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 software deficiency in which the summary of findings (sof) report was displaying deleted test results that had been verified and then subsequently cancelled by the user.When a toxicology test is deleted, none of the associated results should appear in the sof report.The sof 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 of results on the final patient report.When the final patient report is generated the report does not contain the cancelled toxicology results.The software deficiency was addressed to not display deleted tests on the sof report.The issue was resolved in merge (b)(4) software version (b)(4) released july 9, 2018.Merge (b)(4) release notes documents that this issue is resolved under release (b)(4), resolved issues section, (b)(4).Proper toxicology workflow practice would dictate that toxicology results should not be verified prior to completing the validity test on the sample, so if the validity test is rejected, as was the issue with this report, verified drug tests would not need to be cancelled.Actions indicated this is a user error due to the customer not following proper workflow practice when performing their validity/toxicology testing.

• 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
• MDR Report Key: 6474563
• MDR Text Key: 72374861
• Report Number: 2183926-2017-00082
• 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: 03/09/2017

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: 03/09/2017
• Initial Date FDA Received: 04/08/2017
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1