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

Catalog Number 07154003001

Device Problem Computer Software Problem (1112)

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

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer stated that patient results for an unknown test are automatically validated by the cobas infinity core software even though the validation criteria conditions are not met.This occurred with 19 patient samples.The first sample was first registered on the system on (b)(6) 2016.Although the first sample was registered on (b)(6) 2016, it was not clear if this was the date of the event.A clarification has been requested.Information on the affected patients is included in the attachment.The issue could be reproduced in the system as follows: an order is created in the system with a patient for test "6670".A result for the "6670" test is entered and saved.The system will automatically validate the result for test 6670.Based on the validation criteria conditions, it was expected that the test result would not be validated.It was asked, but it is not known if any patients were adversely affected.No adverse events were alleged.

Manufacturer Narrative

The date of event has been confirmed as (b)(6) 2016.

Manufacturer Narrative

Investigations of the software have determined that it behaves as expected since the complained test contained a reference range.Based on the customer's settings, the software applied a rule of "do not validate without ranges".The results of the complained test were automatically validated because a reference range existed in the test configuration, even though the values defining the ranges were empty.The system will verify whether or not the test has a reference range defined, but it does not check whether the range itself contains defined values.This issue may be resolved by disabling the reference range that was configured with empty values or editing the existing reference range to include values.None of the affected patients were harmed.

• 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: 7129734
• MDR Text Key: 96031176
• Report Number: 1823260-2017-03013
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2018

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 Catalogue Number: 07154003001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 11/28/2017; 11/28/2017
• Supplement Dates FDA Received: 12/20/2017; 01/02/2018
• 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
• Patient Age: 66 YR