MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® MPX MULTIPLEX HIV, HCV & HBV NUCLEIC ACID TEST; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV

Catalog Number	06998917190
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	05/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant results for hepatitis b virus (hbv) using the kit cobas 6800/8800 mpx 480t us-ivd assay on the cobas 8800 instrument.The customer reported four reactive hbv results from pooled samples tested on (b)(6) 2021.The individual samples from these pools were identified as follows: (b)(6) (reactive with a cycle threshold (ct) value of 37.3), (b)(6) (reactive with a ct value of 36.1), (b)(6)(reactive with a ct value of 37.5), and (b)(6) (reactive with a ct value of 37.9).Serology testing for these samples was non-reactive.The samples were sent to a third-party laboratory for confirmatory testing using a competitor assay (grifols), which also yielded non-reactive results.The donations were blood and were not released.
Additional Manufacturer Narrative
The reported event occurred on a cobas 8800 instrument (serial number: (b)(6)).The investigation determined that the kit cobas 6800/8800 mpx 480t us-ivd assay performed within specifications.A review of the data provided indicated that the cycle threshold (ct) values for the reactive samples were near, at, or past the limit of detection (lod) of the assay.Growth curves for the reactive samples were indicative of true viral target amplification, and internal controls, as well as positive and negative controls, were robust and sigmoidal, confirming proper assay performance.Discrepant results near the lod are expected and may occur.The samples may represent cases of occult blood infection (obi), where serology is non-reactive, but low levels of the virus are present in the bloodstream.No issues related to the customer allegation were identified in the batch trend analysis, product release review, stability review, internal non-conformance review, or change record review.A trend was not identified.

• Brand Name: COBAS® MPX MULTIPLEX HIV, HCV & HBV NUCLEIC ACID TEST
• 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: 23098326
• Report Number: 2243471-2025-03232
• Device Sequence Number: 18297051
• Product Code: QHO
• UDI-Device Identifier: 00875197004779
• UDI-Public: 00875197004779
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: BL125576
• 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 Expiration Date: 05/31/2021
• Device Catalogue Number: 06998917190
• Device Lot Number: F23153
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2021
• 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