MAUDE Adverse Event Report: SUNQUEST INFOMATION SYSTEMS SUNQUEST COPATHPLUS

Device Problem Implant Mobility NOS (Not otherwise specified) (2645)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

This issue was found by a client while conducting testing in a non-live test area.In copathplus, in the asset matching/reconciliation activity, after populating the unique id field and reconciling an asset (block, slide, etc.), if a user changes to any other activity (such as final diagnosis) by pressing 'f3' (shortcut key for switch activities) or clicking the 'switch activities' icon, any subsequent changes to the current specimen may be lost.

Manufacturer Narrative

A 114 sites have been notified via product safety notice (psn) and a correction will be available in copathplus version 6.1.1 and above.There are 0 sites that have already been corrected.Steps to reproduce: accession new specimen, use 'f3' key to switch activities, note that a dialog box verifying save presents, advance to histology e/e, run protocols, verify that blocks and stains were added to specimen, use 'f3' key to switch activities to asset matching/reconciliation, note that a dialog box verifying save presents reconcile a block.Verify that it displays a reconciled, use 'f3' key to switch activities to any other screen, note that a verification dialog box did not present at this point (this is key), after advancing to next screen (final diagnosis e/e used in this example), modify data in any field.

• Brand Name: SUNQUEST COPATHPLUS
• Type of Device: COPATHPLUS
• Manufacturer (Section D): SUNQUEST INFOMATION SYSTEMS; 250 s. williams blvd; tucson AZ 85711
• Manufacturer Contact: patrice nedelec, vp client experi ; 250 s. williams blvd.; tucson, AZ 85711 ; 5205702317
• MDR Report Key: 3733300
• MDR Text Key: 4272357
• Report Number: 2029302-2014-00003
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 03/24/2014

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: Other
• Other Device ID Number: VERSION 6.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• 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