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	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial numbers of the e 801 analyzers are (b)(6).The lot number and expiration date of the anti-hav reagent were requested, but not provided.The investigation is ongoing.
Event or Problem Description
The customer reported an issue with the cobas infinity software.The issue affected patient samples tested with elecsys anti-hav ii on two cobas e 801 analytical unit analyzers.The result modification rules set up on the cobas infinity software for the anti-hav assay were found to be incorrect.According to product labeling for the anti-hav assay, patient results with results > 1.0 coi are interpreted as non-reactive.Patient results with results < or = to 1.0 coi are interpreted as reactive.The cobas infinity software was set up to modify results from the e 801 analyzers to provide the following result interpretations: coi values of -99999 to 0.90 = non-reactive, coi values of 0.90 to 1.09 = equivocal, coi values of 1.10 to 999999 = reactive.The issue has impacted approximately 167 patient samples that have been tested since (b)(6) 2025.For example, a sample tested on an e 801 analyzer on (b)(6) 2025 resulted in an anti-hav value of 1.06 coi.The value should have been interpreted as non-reactive, but based on the result modification rules set up in cobas infinity, the result was reported as equivocal.
Additional Manufacturer Narrative
The investigation did not identify a product issue.The issue was caused by a mis-configuration of the settings to erroneously include an equivocal result interpretation range.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23657929
• Report Number: 1823260-2025-04881
• Device Sequence Number: 4903799
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 12/17/2025

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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/17/2025
• 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