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	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged false reactive hiv results for two samples tested using the kit s201 t-scrn mpx v2.0 96t us-ivd assay on the cobas s201 instrument.On (b)(6) 2021, sample barcode (b)(4) was reported as reactive for hiv with a cycle threshold (ct) value of 43.06.On (b)(6) 2021, sample barcode (b)(4) was reported as reactive for hiv with a ct value of 34.4.Serology testing for both donor samples was negative.
Additional Manufacturer Narrative
The analysis was performed on a cobas s201 instrument (serial number: (b)(4)).The investigation determined that the cobas® taqscreen mpx v2.0 assay kit batch f31699 performed within specifications.However, the reported false reactive results were substantiated based on the provided data.A review of the sample data revealed that both samples generated relatively flat curves with cycle threshold (ct) values of 43.06 and 34.4, respectively.Serology testing for both donor samples was negative.Non-specific amplification could not be confirmed for sample (b)(4) due to the unavailability of ad plates.The device remains in operation.

• 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: 23098191
• Report Number: 2243471-2025-03225
• Device Sequence Number: 8766304
• 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: 04/30/2021
• 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