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	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analysis was performed on a cobas s201 instrument (serial number: (b)(6)).The investigation determined that the kit s201 t-scrn mpx v2.0 96t us-ivd assay was performing within specifications.A review of the amplification growth curves confirmed that the assay functioned as intended, with robust and sigmoidal growth curves observed for control targets and internal controls of the positive and negative controls.The reactive result for hepatitis c virus (hcv) was associated with a non-sigmoidal growth curve and minimal amplification, along with suppressed internal control amplification.These findings suggest a potential contaminant introduced during sample handling or processing as a possible cause.Non-specific amplification could not be ruled out, and the possibility of the sample being near the assay's limit of detection (lod) was considered but deemed unlikely due to non-reactive serology results.No issues were identified in the batch trend analysis, product release, stability review, or internal non-conformance review.The device remained in operation at the customer site, and no further issues were reported following routine maintenance and decontamination procedures.
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 s201 instrument.On (b)(6) 2020, a sample tested reactive for hepatitis c virus (hcv) with a cycle threshold (ct) value of 42.9.On 03-jul-2020, the same sample was repeated and was non-reactive for all targets.Serology testing for the sample was also non-reactive.Organs were not recovered for donation; however, this decision was not attributed to the reactive result of the mpx test.

• 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: 23096941
• Report Number: 2243471-2025-03198
• Device Sequence Number: 8731107
• Product Code: QHO
• UDI-Device Identifier: 00875197004045
• UDI-Public: 00875197004045
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: 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 Catalogue Number: 05969484190
• Device Lot Number: E32217
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2020
• 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