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	False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged an increase in unexpected hepatitis c virus (hcv) reactive results after switching from the ce-ivd version to the us-ivd version of the kit s201 t-scrn mpx v2.0 96t assay on the control unit blood screening s201 instrument.The customer provided data showing questionable hcv positive results using the mpx v2.0 us-ivd test.It was noted that weak spikes in the growth curves displayed in the amplilink software were observed.These curves, which are visible prior to the application of the algorithm, were ultimately determined to be non-reactive after the algorithm was applied, as indicated by the pdm (post-detection module) result.No harm was alleged, and the questioned positive results did not lead to any organ donation rejections.
Additional Manufacturer Narrative
The reported event occurred on a control unit blood screening s201 instrument with serial number (b)(6).The investigation determined that the higher frequency of unexpected hepatitis c virus (hcv) reactive results observed by the customer when using the mpx v2.0 us-ivd assay was consistent with known differences between the ce-ivd and us-ivd versions of the assay.These differences are attributed to variations in the test definition file (tdf) used to interpret results, as outlined in the product's instructions for use (ifu) and supporting documentation.A review of the provided data confirmed that weak spikes in the growth curves displayed in the amplilink software were observed.However, these curves, visible prior to the application of the algorithm, were ultimately determined to be non-reactive after the algorithm was applied, as indicated by the pdm (post-detection module) result.No issues were identified with the reagents from the investigated lot (g11355), and no trends were observed in the batch trend analysis or complaint history analysis.The device remained in operation at the customer site, and no harm was alleged.The questioned positive results did not lead to any organ donation rejections.

• 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: 23083418
• Report Number: 2243471-2025-03094
• Device Sequence Number: 21266889
• 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): 09/18/2025

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: 02/28/2022
• Device Catalogue Number: 05969484190
• Device Lot Number: G11355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• 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