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	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas s201 instrument with 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 the data provided, including raw data and limit of detection (lod) testing results, indicated that the observed discrepancies in hbv results were likely due to the external quality control material being diluted near the assay's lod.Concentrations near the lod may not yield consistent results, and variability in sample preparation and dilution was identified as a contributing factor.Instrument performance checks, including internal and quality controls, were within expected ranges, and no issues were identified with the system.No product issue was identified, and the root cause was attributed to the external material's preparation and its proximity to the assay's lod.The device remains in operation at the customer site.
Event or Problem Description
The initial reporter alleged discrepant results for the hbv target using the kit s201 t-scrn mpx v2.0 96t us-ivd assay on the cobas s201 instrument.The customer also reported a year-over-year decline in hbv positive rates from 2020 to 2023, raising concerns about potential false negative results.The customer conducted a limit of detection (lod) test for hiv, hbv, and hcv targets using external material from an unknown third-party supplier.The material was diluted to 1xlod for each target, with the hbv target showing discrepancies.Specifically, for the first batch of testing, two samples ((b)(6)) were unexpectedly negative.The external material had a primary concentration of 50 iu/ml and was diluted to 2.5 iu/ml, which is near the assay's lod of 2.3 iu/ml.The customer noted that for lod testing, the validity criteria require 18 out of 20 pools to be positive.The customer observed variation in hbv cycle threshold (ct) values during the first batch of testing, with values ranging from 35.7 to 38.5, which coincided with the false negative results.In contrast, the second batch of testing showed consistent ct values with no false negative results.The internal controls and quality controls (ic/qc) for both batches were similar.The results for the hiv and hcv targets showed less variation, with hcv demonstrating the most consistent data among the three targets.

• 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: 23094362
• Report Number: 2243471-2025-03167
• Device Sequence Number: 12933109
• 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: 04/30/2024
• Device Catalogue Number: 05969484190
• Device Lot Number: J11215
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• 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