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	08/19/2021
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 performed within specifications.Data analysis confirmed the reported results, including the reactive pools and subsequent resolution testing outcomes.A review of complaint history did not identify a trend for lot g16011, and no internal non-conformances related to the reported event were identified.The reactive hiv result observed during resolution testing was attributed to non-specific amplification, which is characterized by late cycle threshold (ct) values and typically does not repeat.The reactive hbv result observed during resolution testing was attributed to potential contamination from an external source during sample preparation, which may occur due to deviations from optimal workflow practices.The customer was advised to follow best practices for sample and reagent handling and to consider cleaning the thermal cycler wells as outlined in the relevant service notice.A reactive pool is considered an interim result, and the resolution testing result should be regarded as the final result.
Event or Problem Description
The initial reporter alleged discrepant results between pool testing and resolution testing using the kit s201 t-scrn mpx v2.0 96t us-ivd on the cobas taqman instrument.On (b)(6) 2021, a pool of 6 samples was reactive for hepatitis c virus (hcv) with a cycle threshold (ct) value of 45.9.Resolution testing of one sample from this pool was reactive for human immunodeficiency virus (hiv) with a ct value of 39.5.Repeat testing of this sample was non-reactive.Serology for this sample was non-reactive.On the same date, a different pool of 6 samples was reactive for hcv with a ct value of 50.5.Resolution testing of one sample from this pool was reactive for hepatitis b virus (hbv) with a ct value of 35.5.Repeat testing of this sample was reactive for hbv with a ct value of 35.1.Serology for this sample 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: 23099288
• Report Number: 2243471-2025-03246
• Device Sequence Number: 20987052
• 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): 09/19/2025

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: 07/31/2022
• Device Catalogue Number: 05969484190
• Device Lot Number: G16011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• 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