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	Incorrect, Inadequate or Imprecise Result or Readings (1535); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged there was an issue with the cobas infinity software.A rule was created in the cobas infinity software to transmit results less than the measuring range of the aspartate amino transferase (ast) assay (measuring range = 5 - 700 u/l) as < 5 u/l.A sample processed on a cobas c 503 analytical unit initially resulted in an ast value of 55.5 u/l accompanied by a data flag indicating a linearity issue.The sample was the automatically diluted 1:10 on the c 503 analyzer and repeated, resulting in an ast value of 43.3 u/l with a data flag indicating the value was below the measuring range of the assay.The result of 43.3 u/l was transmitted to the customer's host system by the cobas infinity software as < 5 u/l.
Additional Manufacturer Narrative
The serial number of the customer's c 503 anlayzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The result modification occurred due to a system setting called "result modification by range" under the "ica instrument definition" setting.In this case, the received ast test result triggered the alarm code "27" (for results exceeding the limit of quantification), and consequently, the system applied the modification, resulting in the final reported value of "<5 u/l".The investigation did not identify a software issue in cobas infinity.The result modification was triggered by the "result modification" by range configuration of the system.

• 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: 21872741
• Report Number: 1823260-2025-01202
• Device Sequence Number: 7719612
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 04/30/2025

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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/30/2025
• 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