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

Catalog Number	07154003001
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they had an issue with the cobas infinity software.An ast test result for a patient sample was automatically validated in the cobas infinity software due to a missing flag and the result was released outside of the laboratory to the patient.The result should have been blocked by the cobas infinity software for manual validation.
Additional Manufacturer Narrative
Investigations have determined that under certain circumstances, the automatic validation process is executed before cobas infinity has added the corresponding alarm to the test result, preventing the result from being blocked from automatic validation.The observed behavior has been confirmed as a software issue in cobas infinity, and the necessary circumstances to make the issue arise are described as follows: 1) there is an order with two tests t1 and t2.2) t1 result is registered in cobas infinity.The results are within the reference range, so no alarms are added.The validation event is generated.3) when the automatic validation process is executed, it detects the pending validation event and evaluates the whole order to determine what is pending for validation.4) while the automatic validation process is evaluating the order, an alphanumeric t2 result is registered in cobas infinity.Before cobas infinity can add the corresponding alarm to t2, the automatic validation process validates both t1 and t2 results (as there are no yet alarms in t2).5) when cobas infinity adds the alarm to t2 result, the result has already been incorrectly validated.Even though a new validation event is generated, when the automatic validation process checks the order it detects that there is nothing pending to validate, so no additional actions are performed on the order.

• Brand Name: COBAS INFINITY CORE SOFTWARE
• Common Device Name: 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: 13549808
• Report Number: 1823260-2022-00414
• Device Sequence Number: 5269278
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 07154003001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown