MAUDE Adverse Event Report: MERGE HEALTHCARE ICONNECT ACCESS; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number ICONNECT ACCESS (V.5.1)

Device Problem Patient Data Problem (3197)

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

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

Upon review, this issue was determined to be reportable as an mdr.

Event Description

Iconnect access is a zero-footprint, zero-download dicom and xds viewer that provides diagnostic quality image review for referring physicians.By providing easy access to images and content, iconnect access benefits providers by providing quality service levels to referring physicians.Currently the patient comparison strategy used in the image sharing solution is pid (patient id)+ipid (issuer of patient id).The result of this is that when two separate patients who have the same pid are merged in the holding pen, specifically the demographics on the first exam uploaded are updated to the demographics on the second exam uploaded.Scenario: a user with administrative system privileges, (b)(6) uploads exam 1 for patient (b)(6) (with additional demographics), (b)(6).A user with the proper credentials can search for (b)(6) and find exam 1 with the demographics that were associated with the exam when (b)(6) uploaded the exam.(b)(6) now uploads exam 2 for (b)(6) (with additional demographics), (b)(6).Desired behavior: (b)(6) can search for (b)(6) and find exam 2 and search for (b)(6) and find exam 1.It is understood and accepted in the industry that variations in the search terms will impact the accuracy and completeness of the search, e.G.Searching for (b)(6) would return exam 1 while searching for (b)(6) would not find exam 1.Actual behavior: if (b)(6) searches for (b)(6), the system will return both exam 1 and exam 2.And if (b)(6) searches for (b)(6), the system will return no results.Note that this issue only arises when two (or more) exams have been imported that have the same ipid / pid combinations, and the second exam is uploaded before the first exam has been reconciled against a patient in the archive or against an order.Both customers, (b)(6), who are aware of this behavior have stated that it is not acceptable and that they require a change to be made to the system to obtain the desired behavior.This issue was discovered first by (b)(6) which communicated this issue to (b)(6).While discussions around this solution are ongoing with (b)(6), (b)(6) has indicated that they view this as potentially impacting patient care that needs to be corrected as soon as possible.

• Brand Name: ICONNECT ACCESS
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• 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: 5378495
• MDR Text Key: 36350397
• Report Number: 2183926-2015-00197
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ICONNECT ACCESS (V.5.1)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2015
• 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