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	01/23/2021
Type of Reportable Event	Malfunction
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 s201 instrument.The customer was conducting a validation study comparing the ce-ivd version of the assay to the us-ivd version of the assay.On (b)(6) 2021, 60 samples were tested with the ce-ivd version, and all were non-reactive for hiv, hepatitis b virus (hbv), and hepatitis c virus (hcv).On (b)(6) 2021, the same 60 samples were tested with the us-ivd version, and one sample was reactive for hiv, hbv, and hcv, with cycle threshold (ct) values of 35.8, 36.7, and 40.3, respectively.Serology testing for this sample and all other samples was non-reactive for all three targets.The blood donation was not released.
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 was performing within specifications.A systems assessment confirmed that an increased volume in the s-tube would not lead to an unexpected reactive result.The most likely cause of the discrepant result was identified as a deviation from optimal workflow when handling the multi-positive control (mpc) vial and the sample.A review of batch trends, product release, stability, internal non-conformance records, and change records did not identify any issues related to the customer allegation.The customer was advised to ensure adherence to optimal sample and reagent handling workflows.

• 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: 23086528
• Report Number: 2243471-2025-03131
• Device Sequence Number: 9796326
• Product Code: QHO
• UDI-Device Identifier: 00875197004045
• UDI-Public: 00875197004045
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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 Expiration Date: 06/30/2021
• Device Catalogue Number: 05969484190
• Device Lot Number: F31696
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2021
• 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