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

Catalog Number	09040820190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas (b)(6).Investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results for a single patient using the cobas® hbv quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems.On (b)(6)2024, the alleged sample was tested on a competitor's assay (sansure platform), generating a positive result of 1.39e+4 iu/ml and 8.8e+3iu/ml, respectively.On (b)(6) 2024, the same sample was repeated three times on the cobas 6800 system, generating a target not detected (negative) result each time.According to the sequencing results provided by the customer, sansure showed that it was hbv c subtype.On (b)(6) 2024, the sample was tested on another platform (hbv dna quantitative detection by daan gene) which was negative.As the only positive results were generated with the sansure assay, the customer combined the patient's clinical presentation, serological results, and the hbv dna test results from multiple manufacturers and released the sample as negative.
Additional Manufacturer Narrative
The reagent investigation determined that no product issue was identified, and the reagent kit is working as intended.A mutation is likely present under our primers and probes, causing an under-quantification.

• 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: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876
• MDR Report Key: 20635151
• Report Number: 2243471-2024-03218
• Device Sequence Number: 15296089
• Product Code: MKT
• UDI-Device Identifier: 00875197006414
• UDI-Public: 00875197006414
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 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 Expiration Date: 10/31/2025
• Device Catalogue Number: 09040820190
• Device Lot Number: K22134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2024
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 11/07/2024
• 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