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

Catalog Number	09040820190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going.
Event or Problem Description
A customer from japan alleged discrepant results for a single patient when using the cobas hbv quantitative assay for use on the cobas 58/68/8800 systems.The alleged sample initially generated titer max result on (b)(6) 2023.On (b)(6) 2023, the same sample was retested and generated an invalid result.On (b)(6) 2023, the same sample was retested and generated a target not detected (tnd) result.A competitor serology test (details unknown) for hepatitis b core antigen was positive.
Additional Manufacturer Narrative
A review of the data showed that the sample had a curve indicative of a positive result with an unusual shape.The investigation determined that due to the unusual curve shape, the algorithm could not calculate an appropriate curve.An optimization of the settings is planned for a future version of the software to address the issue.At this time, this is the only complaint related to this issue.

• 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: 17653412
• Report Number: 2243471-2023-02824
• Device Sequence Number: 15273382
• Product Code: MKT
• UDI-Device Identifier: 00875197006414
• UDI-Public: 00875197006414
• Combination Product (Y/N): Y
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: 08/31/2024
• Device Catalogue Number: 09040820190
• Device Lot Number: K02050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 12/07/2023
• 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