MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY LAB CORE LICENSE 3.X; CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE

Catalog Number	09180443001
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter stated there was an issue with the cobas infinity software.The customer alleged that patient results observed in the evolution (validation), patient history (validation), and history/evolution charts (order search) sections of the cobas infinity software are not presented in a chronologically correct order.The software uses the order creation date instead of the sample collection date to place samples in chronological order.The customer alleges this could possibly give a misleading picture of the patient's progress to the clinicians reviewing the sample results through the evolution, patient history, or history sections of the software.
Additional Manufacturer Narrative
The customer states that the same issue is occurring in other sections of the cobas infinity software.The 'last result in previous orders' column in work areas\validation also follows the same faulty logic.The 'value of previous result' field used in variables/rule engine also follows the same faulty logic.The investigation confirmed the alleged behavior as a software issue since parameters in the cobas infinity software are ordered based on the "creation date", causing interpretation issues.

• Brand Name: COBAS INFINITY LAB CORE LICENSE 3.X
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17977055
• Report Number: 1823260-2023-03378
• Device Sequence Number: 11389175
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (Y/N): Y
• Initial Reporter Country: NO
• 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): 11/03/2023

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: 09180443001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 10/22/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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