MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV

Catalog Number	05969484190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analysis was performed on a cobas s201 instrument (serial number: (b)(6).The investigation determined that the kit s201 t-scrn mpx v2.0 96t us-ivd assay performed within specifications.The discrepant results were attributed to the sample being a low-titer sample for hepatitis b virus (hbv), with a viral concentration near or at the limit of detection of the assay.This can result in wavering results between reactive and non-reactive outcomes, which is an expected behavior for such samples.No product issue was identified, and the associated blood bag was discarded by the customer.A definitive root cause for the reported event was determined to be sample-specific.
Event or Problem Description
The initial reporter alleged a false reactive result for hepatitis b virus (hbv) when using the kit s201 t-scrn mpx v2.0 96t us-ivd assay on the s201 instrument.The customer workflow involved testing a primary pool of 6 (pp6) samples.On (b)(6) 2024, the pp6 generated a reactive result with a cycle threshold (ct) value of 36.9.The customer repeated the resolution testing, and all six individual samples were non-reactive.Subsequently, the customer retested all samples from the same aliquot at the individual sample level (pp1), and one sample generated a reactive result with a ct value of 36.5.No harm was alleged, and the associated blood bag was discarded.

• Brand Name: COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM
• Common Device Name: HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV
• 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: 23099607
• Report Number: 2243471-2025-03261
• Device Sequence Number: 8765403
• Product Code: QHO
• UDI-Device Identifier: 00875197004045
• UDI-Public: 00875197004045
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: BL125459
• 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
• Report Date (Section B): 09/19/2025

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: 06/30/2025
• Device Catalogue Number: 05969484190
• Device Lot Number: K18133
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 09/19/2025
• 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