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 Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable hcv result for one patient sample with the cobas® taqscreen mpx test, version 2.0 for use on the cobas s 201 system.On (b)(6) 2025, the initial pooled result was hcv reactive.Alinity abbott serology results: reactive for hcv (2.1 s/co), serum repeat (2.3 s/co), plasma repeat (1.77 s/co).A confirmatory test was performed (inno-lia hcv score fujirebio) and the results for this were: positive 4 bands out of 6 (c1 +, c2 +, e2 -, ns3 +, ns4 +, ns5 -).In (b)(6) 2025, the donor donated at another blood bank (using roche nat platform) and the result was undetectable for hcv.On (b)(6) 2026, the recollected individual result was hcv non-reactive.Alinity abbott serology results: reactive for hcv (2.17 s/co).
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation indicated that no product issue was found.The undetectable viral load in the individual nat sample is most likely due to the biological status of the donor, either a spontaneous resolution of a chronic hcv infection or a chronic asymptomatic infection with a fluctuating, low-level viral load.The inconsistency between the reactive nat pool and the non-reactive individual nat is attributed to the stochastic nature of sampling when viral rna is at an extremely low concentration (near the limit of detection).

• 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: 24312532
• Report Number: 2243471-2026-00461
• Device Sequence Number: 17362284
• Product Code: QHO
• UDI-Device Identifier: 00875197004045
• UDI-Public: 00875197004045
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 02/11/2026

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: 01/31/2026
• Device Catalogue Number: 05969484190
• Device Lot Number: M17931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/11/2026
• 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 Age: 57 YR
• Patient Sex: Male