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 Output Problem (3005)

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

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

An internal investigation was performed.Merge healthcare determined that there was a deficiency in the merge lis software version the customer was utilizing.Should a reference lab cancel a test in the middle of the hl7 result message, tests and accessions following the cancelation may not be processed as expected and there is the potential that results may not appear in merge lis.Modifications to the software were made in lis v.4.1.6 to mitigate this issue and to ensure that all reference lab results are received.The customer was upgraded to lis v.4.1.6 on (b)(6) 2017.It should be noted that lis users have tools available to identify patient's with pending results.Among those tools are the pending report described in merge lis v.4.1.4 user manual, chapter 10 management report, pending report, which lists all of the patients with laboratory work still pending completion.Also review of the worklist will indicate if patients have been transmitted to the reference lab.Once all results have been received they are cleared from the worklist screen.If the customer identifies that a lab test has not been received, the customer can contact the reference lab and have the reference lab send the results to the required recipients without the use of the lis.Additionally, most reference labs offer patient/provider portals in which the provider can view/retrieve patient results.

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 customer reported two reference lab patient results were not being processed by merge lis and remained pending in their lis worklist.Merge healthcare identified that completed reference lab test results were not being processed by merge lis for tests following a canceled test by the reference lab, on both patient accessions.To resolve the issue for one sample, merge healthcare deleted the pending test and finalized the order for the customer.The sample results had already been scanned into the database by the customer.For the second sample, merge healthcare upgraded the customer from lis v.4.1.5 patch 1 to lis v.4.1.6.The reference lab was able to retransmit the results for the sample to merge lis successfully.With merge lis not receiving reference lab 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).

• 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: 6394108
• MDR Text Key: 69570724
• Report Number: 2183926-2017-00053
• 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: 02/09/2017

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 4.1.5 PATCH 1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• 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