MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® HBV (192T); HEPATITIS VIRAL B DNA DETECTION

Catalog Number	09040820190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable result with the cobas® hbv (192t) assay for a patient sample tested on the cobas 5800 analyzer.On (b)(6) 2025, the initial result was target not detected.The sample was repeated using a competitor method (alinity m) and the result was 3.69 log (4897.79).On (b)(6) 2025, the sample was repeated twice on the cobas 5800 and the results were 3.29 log (1949.84) and 3.20 log (1584.89), respectively.
Additional Manufacturer Narrative
The serial number of the analyzer was requested but not provided.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch field d4 was updated.The investigation did not reveal a product issue with the reagent lot number, m26984.No related internal investigations were found.While the specific root cause remains unknown, evidence points to pcr inhibition caused by the presence of high concentrations of inhibitory substances in the sample tested on 16-oct-2025.These inhibitors may include particulate matter, precipitated proteins, or lipids that can naturally occur in patient samples.The investigation did not identify a product problem.

• Brand Name: COBAS® HBV (192T)
• Common Device Name: HEPATITIS VIRAL B DNA DETECTION
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 23556197
• Report Number: 2243471-2025-04642
• Device Sequence Number: 18655189
• Product Code: MKT
• UDI-Device Identifier: 00875197006414
• UDI-Public: 00875197006414
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150014/S043
• 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): 12/03/2025

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: 09040820190
• Device Lot Number: M26984
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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