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	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas taqman instrument with serial number (b)(6).The investigation determined that there were no indications of a product issue or hardware malfunction associated with the kit s201 t-scrn mpx v2.0 96t us-ivd assay.A review of the provided data and manufacturing trend lines did not identify any reagent or product-related contributions to the reported issue.Instrument assessment indicated a minor disturbance in the optical path, which did not impact the assay results.The relative fluorescence intensity (rfi) values, critical for result evaluation, were unaffected.No related product trends, internal non-conformances, or escalated complaints were identified for the reagent lots in question (g11355 and g29865).The root cause for the observed differences in hbv positive rates between 2021 and 2022 could not be determined based on the available information.The device remains in operation at the customer site, and no harm was alleged as a result of the reported event.
Event or Problem Description
The initial reporter alleged a decrease in the hepatitis b virus (hbv) positive rate when using the kit s201 t-scrn mpx v2.0 96t us-ivd assay on the cobas taqman instrument.The customer reported that in 2021, they tested (b)(4) donor samples using the mpxv2.0 assay in pp6 mode and observed 25 hbv positive results out of 38 positive pools, which was comparable to the results obtained with the ce version of the assay.For human immunodeficiency virus (hiv), no positive results were observed out of 4 positive pools, and for hepatitis c virus (hcv), 1 positive result was observed out of 13 positive pools.These results were also comparable to those obtained with a competitor assay.In 2022, the customer tested 14,385 donor samples using the mpxv2.0 assay and observed 3 hbv positive results out of 9 positive pools, 1 hiv positive result out of 3 positive pools, and no hcv positive pools.During the same period, the competitor assay detected 16 hbv positive results out of 18 positive pools and 1 hiv positive result out of 3 positive pools in 21,796 donations.The hbv positive rate appeared to be lower with the mpxv2.0 assay on the cobas taqman instrument compared to the competitor assay.

• 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: 23099593
• Report Number: 2243471-2025-03265
• Device Sequence Number: 15624715
• 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: 10/31/2022
• Device Catalogue Number: 05969484190
• Device Lot Number: G29865
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• 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