MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY CORE SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 07154003001

Device Problem Patient Data Problem (3197)

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

Event Date 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained that non-validated comments are being sent to their external software from the cobas infinity software version 1.1.1.To reproduce the issue, the customer created an order for tests 1503 and 6256.The customer placed a result with test 1503 and a comment to test 6256.Test 1503 was validated.The customer expected that only test 1503 would be sent as it was the part that was validated.What occurred was that test 1503 was sent along with the comment from test 6256 that had not been validated.The comment section could contain clinical data for a patient that was not validated with the associated test result.These comments would be visible to hospital staff dealing directly with patients.There was no allegation that an adverse event occurred.

Manufacturer Narrative

The investigation was able to reproduce the customer's allegation in a virtual environment.The cobas infinity software uses an internal printing configuration to manage the information sent to the external host.The printing configuration is set as either nimp (non-printable) or imp (printable).The investigation created an order with 2 tests: nimp and imp.Results were added to both tests and a comment was only added to the imp test.Only the nimp test was validated.Cobas infinity software is configured to send information to the host once a test has been printed by the trigger option "report print".The result was that the nimp test was sent to the host with the result.The imp test (which was not validated) was sent to the host with no result but with the comment.This behavior for the imp test is incorrect as only validated tests/comments should be sent to the host.The root cause of the issue is that comments of non-validated tests are not taken into account in the management of the information that should be sent to the host from the cobas infinity software.This was confirmed to be a software issue.

• Brand Name: COBAS INFINITY CORE SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6760143
• MDR Text Key: 81613419
• Report Number: 1823260-2017-01582
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07154003001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1