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	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they encountered an issue with the cobas infinity software.The customer was manually validating a set of results associated with a first patient in the cobas infinity software.The results for this first patient appeared to have changed over to "validated" in the software and then the patient demographics updated to a second patient.When the patient demographics were updated, the associated test results should have been updated too, but the second patient's demographics were associated with the first patient's results.The user was using the "validate all" function within the main>work areas>patient reports screen of the software.The customer provided an example of one order id, (b)(6), which had a lactic acid result that was validated.The demographics updated and populated the order id of the next patient, (b)(6).Order id (b)(6) should have displayed a vancomycin result, however, the lactic acid result from id (b)(6) stayed on the screen and appeared linked with order id (b)(6).The user backed out of the work areas screen and went back in.When the user went back into the screen, the anticipated vancomycin result was then displayed for order id (b)(6).No questionable test results were reported outside of the laboratory.
Additional Manufacturer Narrative
H3: na.
Additional Manufacturer Narrative
The customer reported that the issue occurred again on (b)(6) 2023.The user was validating results and she noticed that order id/patient id a's results displayed as expected under the demographic information.However, after validation, patient a's results stayed on the screen, even though patient b's demographic information and order id populated alongside the previous patient's results.During each occurrence of this issue, the user realized the results on the screen didn¿t match the patient demographics, so they backed out of the screen.No incorrect results were reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation determined there was an issue with the cobas infinity software which causes the cobas infinity to not correctly handle exceptions when loading a new order inside the validation screen of a work area.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16919303
• Report Number: 1823260-2023-01610
• Device Sequence Number: 20534435
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 06/07/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/02/2023; 06/23/2023
• 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