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	04/26/2021
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.The customer's allegation of discrepant results was substantiated; however, no harm was alleged, and the questioned reactive results did not lead to an organ donation rejection.A review of batch trend analysis and complaint history for lot f31699 did not identify any trends.The device remained in operation at the customer site.Medwatch field e1: email address was provided as (b)(6).
Event or Problem Description
The initial reporter alleged discrepant results with the kit s201 t-scrn mpx v2.0 96t us-ivd assay on the cobas taqman instrument.The allegation involved a pool of 6 samples that generated a reactive result for hiv with a cycle threshold (ct) value of 42.6.The customer noted that the growth curve displayed in the amplilink software was unclear.When the sample in question was tested in a resolution pool of 1, a non-reactive result was generated.The customer subsequently retested the same sample and obtained another non-reactive result.The donation associated with the sample was released.

• 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: 23098181
• Report Number: 2243471-2025-03226
• Device Sequence Number: 8765834
• 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: 09/30/2021
• Device Catalogue Number: 05969484190
• Device Lot Number: F31699
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2021
• 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