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

Catalog Number	09040820190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable cobas® hbv (192t) results for a patient sample tested on a cobas 6800 analyzer.On (b)(6) 2025: the initial result was 16700 iu/ml.On (b)(6) 2025: the repeat result on the same analyzer was target not detected.On (b)(6) 2025: the repeat result on a second cobas 6800 analyzer was
Additional Manufacturer Narrative
The investigation did not identify a product problem.The root cause was determined to be most likely either pre-analytical sample handling or cross-contamination from a high-titer sample located near the alleged sample.

• 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: 23438079
• Report Number: 2243471-2025-04437
• Device Sequence Number: 4758583
• Product Code: MKT
• UDI-Device Identifier: 00875197006414
• UDI-Public: 00875197006414
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 11/20/2025

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: N06066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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