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	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas taqman analyzer with 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 data confirmed that the sample produced discrepant results, at the customer site with a reactive result (ct value: 38.3) and a non-reactive result at the second lab.The third lab, which used a pooled testing method, also reported a non-reactive result.No abnormalities were identified in the data reviewed, and no reagent issues were observed.The most likely root cause was attributed to the sample being at or near the limit of detection (lod), which could explain the variability in results across different testing sites and methods.No results were reported to the patient, and no harm was alleged.The device remains in operation at the customer site.
Event or Problem Description
The initial reporter alleged a false non-reactive result for hepatitis b virus (hbv) using the kit s201 t-scrn mpx v2.0 96t us-ivd assay on the cobas taqman instrument.A patient sample was initially tested on 06-jun-2023, where serology results showed a positive hepatitis b surface antigen (hbsag) result of 2404 and a positive anti-hepatitis b core antibody (anti-hbc) result of 0.09.The sample was subsequently tested on the cobas taqman instrument, yielding a reactive result with a cycle threshold (ct) value of 38.3 for hbv.On the same day, an aliquot of the sample was sent to another lab for confirmation.The second lab processed the sample individually on one of its four cobas taqman instruments and obtained a non-reactive result.Imunolab did not perform serology testing.The aliquot was transported refrigerated to imunolab.The same tube used for serology testing was sent to a third lab for additional confirmation.The third lab tested the sample using a pooling method (pp6) and obtained a non-reactive result.The cusotmer and the second lab tested the sample as individual donor testing (idt), while the third lab used pooled testing.No results were reported, and no harm was alleged.

• 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: 23100359
• Report Number: 2243471-2025-03297
• Device Sequence Number: 9504039
• Product Code: QHO
• UDI-Device Identifier: 00875197004045
• UDI-Public: 00875197004045
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: 02/29/2024
• Device Catalogue Number: 05969484190
• Device Lot Number: J12482
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• 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