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 Negative Result (1225); 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	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant results when using the kit s201 t-scrn mpx v2.0 96t us-ivd assay on the cobas taqman instrument.On (b)(6) 2023, a sample was tested in a pool of 6 (pp6) and was non-reactive for all targets.Serology testing for the same sample was reactive for human immunodeficiency virus (hiv).The sample was subsequently tested in resolution (resp1) and was reactive for hiv with a cycle threshold (ct) value of 38.The sample was later tested with a quantitative assay, which detected a low concentration of viral target with a value of less than 20 copies per milliliter (cp/ml).The donation was blood, and it was not used.
Additional Manufacturer Narrative
The analysis was performed on a cobas taqman instrument (serial number: (b)(6)).The investigation determined that the kit s201 t-scrn mpx v2.0 96t us-ivd assay performed within specifications.A review of the data provided indicated that the target curve for hiv was robust and sigmoidal, consistent with true viral target amplification.Positive and internal controls also demonstrated robust and sigmoidal curves, confirming proper assay performance.No issues were identified in the quality control data or the reagent kit that could contribute to the reported event.The most likely cause of the unexpected non-reactive result in the pooled sample (pp6) was attributed to the viral concentration being diluted to the assay's limit of detection, where wavering results between reactive and non-reactive may occur.Clinically, the donor may represent a true-positive hiv case with suppressed viral load due to treatment.A trend analysis for lot h30808 did not identify any related issues.The donation was not used, and no additional harm or delay in treatment was reported.

• 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: 23100336
• Report Number: 2243471-2025-03292
• Device Sequence Number: 15644834
• 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: 06/30/2023
• Device Catalogue Number: 05969484190
• Device Lot Number: H30808
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• 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