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	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant results for hiv and hbv when using the kit s201 t-scrn mpx v2.0 96t us-ivd assay on a cobas s201 instrument.On (b)(6)2023, a sample tested in a pool of 6 (pp6) was non-reactive for hiv and reactive for hbv with a cycle threshold (ct) value of 35.7.On (b)(6)2023, the sample was tested using a competitor nucleic acid testing (nat) assay in a pool of 1 (pp1) and was reactive for hiv with a ct value of 40.26.On (b)(6)2023, the sample was repeated in resolution (resp1) and was non-reactive for hiv and reactive for hbv with a ct value of 34.6.Serology results for the sample were reactive for hiv with two different serology tests and non-reactive for hepatitis b surface antigen (hbsag).The blood donation associated with the sample was destroyed.
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.A review of quality control data and complaint history for lot h18082 did not identify any issues related to the reported event.Images of the sample result report confirmed the sample was reactive for hbv and non-reactive for hiv.The target curve for hbv was robust and sigmoidal, indicative of true viral target amplification.The most likely cause of the hbv results is a true low-level hbv infection detectable by the more sensitive roche assay.For the hiv results, the most likely cause of the non-reactive roche nat compared to the competitor assay is that the sample may have an hiv concentration near the assay's limit of detection, where wavering results can occur.Clinically, the donor may have a suppressed viral load for hiv and be undergoing treatment.The reagent kit was investigated, and no issues were identified.A definitive root cause for the reported event could not be determined based on the available information.

• 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: 23100419
• Report Number: 2243471-2025-03293
• Device Sequence Number: 9383058
• 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: 05/31/2023
• 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: 03/31/2023
• 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