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	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number was not provided.The investigation determined that the kit s201 t-scrn mpx v2.0 96t us-ivd assay was performing within specifications.A review of the data confirmed that the growth curves for all reactive results were robust and sigmoidal, indicating amplification of true viral targets.Positive and negative controls were also robust and sigmoidal, confirming proper assay functionality.No issues were identified in the quality control data or the reagent lot h06828.The most likely cause of the discrepant results was attributed to the viral concentration of the pool being near, at, or past the limit of detection (lod) of the assay, where wavering results between reactive and non-reactive may occur.The dilution effect in pooled samples likely contributed to the observed discrepancies.Clinically, the donor sample may represent either an occult hbv infection or a window period sample where serological responses are absent or diminished.A definitive root cause for the reported event could not be determined based on the available information.
Event or Problem Description
The initial reporter alleged discrepant results for hepatitis b virus (hbv) testing using the kit s201 t-scrn mpx v2.0 96t us-ivd assay.On (b)(6) 2022, the customer tested a pool of 6 samples on an s201 system, which generated a reactive result for hbv with a cycle threshold (ct) value of 37.6.However, the result could not be transmitted to the database due to a data transmission issue.On (b)(6) 2022, the customer repeated the pool of 6 samples on another s201 system, and the result was non-reactive.On (b)(6) 2022, the customer tested an individual donor sample from the reactive pool on (b)(6) 2022, and the result was hbv reactive.The blood donation was not used.On (b)(6) 2022, the customer performed additional testing on the plasma from the plasma bag of the same donor sample, which was again hbv reactive.The ct values for the individual donor sample were 33.5 and 35.2 in repeated tests.The growth curves for all reactive results were robust and sigmoidal, indicating amplification of true viral targets.Positive and negative controls were also robust and sigmoidal, confirming that the assay was functioning as intended.

• 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: 23099981
• Report Number: 2243471-2025-03272
• Device Sequence Number: 9347399
• 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: 01/31/2023
• Device Catalogue Number: 05969484190
• Device Lot Number: H06828
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• 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