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 Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analysis was performed on a cobas taqman instrument (serial number: (b)(6).The investigation determined that the kit s201 t-scrn mpx v2.0 96t us-ivd assay was performing as intended.Data analysis revealed that the initial reactive result for hcv showed late, non-sigmoidal amplification, which is indicative of non-specific amplification and does not typically repeat.The repeat test for hbv showed early, sigmoidal, but minimal amplification, which was most likely caused by contamination due to deviations from optimal reagent and sample handling workflow.Positive and negative controls, as well as internal controls, demonstrated robust and sigmoidal amplification, confirming proper assay functionality.No trend was identified for the reagent lot h18062.The root cause for the discrepant hcv result was attributed to non-specific amplification, while the discrepant hbv result was most likely due to contamination.The device remains in operation at the customer site, and the customer was advised to follow optimal workflow practices during sample and reagent handling.
Event or Problem Description
The initial reporter alleged discrepant results when using the kit s201 t-scrn mpx v2.0 96t us-ivd assay on the cobas taqman instrument.The event involved a pool of 6 samples initially tested on (b)(6) 2022, which generated a reactive result for hepatitis c virus (hcv) with a cycle threshold (ct) value of 44.2.The pool was retested on the same day and generated a non-reactive result for hcv but a reactive result for hepatitis b virus (hbv) with a ct value of 4.9.Serology testing for both hcv and hbv was non-reactive.

• 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: 23088668
• Report Number: 2243471-2025-03145
• Device Sequence Number: 9796394
• Product Code: QHO
• UDI-Device Identifier: 00875197004045
• UDI-Public: 00875197004045
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/18/2025

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: 05969484190
• Device Lot Number: H18062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2022
• Initial Report FDA Received Date: 09/18/2025
• 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