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 Codes	Computer Software Problem (1112); Program or Algorithm Execution Problem (4033)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of a software malfunction in the cobas infinity lab core license 3.X.The reporter stated that the rule that adds a result to test number 55 (hcv-res) and deletes the tests hcv-val and hcv-log was not executed and an incorrect result was released to their laboratory information system (lis).The reporter detected the issue in the lis; no patient was harmed.
Additional Manufacturer Narrative
The software version is 3.03.17.The investigation is ongoing.
Additional Manufacturer Narrative
The customer was not able to provide the cobas infinity's exception traces at the time of the event.The investigation could not confirm the reason why the rule was not triggered as expected in the instrument.The investigation determined that the event could not be verified as a software issue in cobas infinity.The investigation did not identify a product problem.

• 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: 18675954
• Report Number: 1823260-2024-00382
• Device Sequence Number: 7309338
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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): 02/29/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 02/29/2024
• 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