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 Patient Involvement (2645)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

An issue was identified with cobas infinity core software version 2.1.5 when a test is modified (e.G.The primary unit, test name).When a test is modified, a new test version is not created, only the current test version is updated.When a test is modified and the primary units are changed, this modification will affect the units of the results that were already validated with the original primary unit.This could also affect the report where 2 reports would have the same numeric result with different units of measure.The following is an example of what could happen: the customer could have a patient test that was created in the software on (b)(6) 2017 with a unit of measure of "mg." an order for this patient test is created on (b)(6) 2017 which contains the test result from (b)(6) 2017.The last version of the test available is the one created on (b)(6) 2017 and this is the one that will be included in the order.If the customer decides that the test needs to be changed and the primary unit of measure is modified from "mg" to "g", a pop-up will be generated and the customer will confirm the change.The software will update the existing version instead of creating a new version.When this patient visits the doctor next and the doctor accesses the patient's previous order and prints out the test results, the units that appear with the first test on (b)(6) 2017 will be the new units with the same numeric result.If the patient test result from (b)(6) 2017 was "100 mg", it will be displayed and printed as "100 g." if a modification is made to a patient test result, the user confirms the change by pressing the "confirm" button.When this is done, the software should check the date of the test result to determine if a new test version should be created.A new test version should be created when the date of the test result is in the past.A new test version will not be created if the date of the test result is "today" or in the future.A pop-up message will appear explaining what the software is going to do and requests the user to confirm.When a new test version is created all the test results obtained in the previous test version are not affected by the change.No patients were affected or harmed by this issue.The investigation confirmed that in cobas infinity core software versions 2.1.0 through 2.1.5 when a patient test result is modified, a new test version is not created and only the current version is updated with the new date.It was verified that cobas infinity core software versions prior to 2.1.0 are not affected by this issue.A pop-up message does occur and informs the user that the current test version will be changed and requests the user to confirm.There is no option to edit a test and create a new test version.The pop-up message is correct, however, the software decision is not correct.The investigation confirmed a software issue.The root cause is an error in the source code.The date used by the software to determine whether a new test version needs to be created or not is that it is always using "today's" date.This occurs because when a test is edited, the date field in the screen is modified to "today" as this is the date of the new test version.However, when the confirmation is performed, rather than using the test date version, the "date" field from the screen is used that was set to "today." the software should store the date of the original test version in a different parameter that cannot be overwritten.A possible workaround is to use the "test reference range" option prior to making a change to the test result.When a user selects "test reference range" a pop-up appears asking whether to create a new test version.When the new test version is created, the user can go back to the test screens and modify the test information.The software will update with the newly created test version.

• 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: 7230659
• MDR Text Key: 98981739
• Report Number: 1823260-2018-00278
• 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
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• 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: 01/16/2018
• 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