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	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	11/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged unexpected reactive results for hepatitis b virus (hbv) using the kit cobas 6800/8800 mpx 480t us-ivd on the cobas 8800 instrument.The allegation involves three samples from long-time non-reactive donors tested on (b)(6) 2020.The samples were identified as (b)(6), which generated reactive results for hbv with cycle threshold (ct) values of 38.4, 38.31, and 38.47, respectively.Samples from the same draw of each donor, but from different tubes, were tested as non-reactive for hbv.Additional testing using a competitor nucleic acid testing (nat) assay (grifols) and serology for all three donors were non-reactive.The donations were not released.Two additional samples tested on the same date, identified as (b)(6), also generated reactive results for hbv with ct values of 6.39 and 6.25, respectively.However, no allegation was made regarding these two samples.
Additional Manufacturer Narrative
The reported event occurred on a cobas 8800 analyzer (serial number: (b)(6).The investigation determined that the cobas mpx assay performed within specifications.Growth curve analysis for the three alleged samples showed late, minimal, non-sigmoidal amplification, while internal controls and assay controls were robust and sigmoidal as expected, indicating proper assay functionality.The most likely root cause for the unexpected reactive results in the three samples was identified as low-level viral contamination during pre-analytical sample handling.This conclusion was supported by the late cycle threshold (ct) values, negative serology results, and non-reactive repeat nat testing using a competitor assay.Additionally, no issues were identified in the batch trend analysis, product release review, stability review, or internal non-conformance review for lot: f23153.The device remains in operation, and no further actions were deemed necessary as the risks were assessed to be acceptable.

• 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: 23064145
• Report Number: 2243471-2025-02887
• Device Sequence Number: 15963647
• Product Code: QHO
• UDI-Device Identifier: 00875197004779
• UDI-Public: 00875197004779
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/16/2025

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: 12/10/2020
• Initial Report FDA Received Date: 09/16/2025
• 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