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	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant results for hepatitis b virus (hbv) when using the kit cobas 6800/8800 mpx 480t us-ivd assay on the cobas 8800 instrument.On (b)(6) 2022, two aliquots were taken from the same donor sample.One aliquot generated a reactive result for hbv with a cycle threshold (ct) value of 36.8, while the other aliquot generated a non-reactive result.Serology testing for the sample was non-reactive.
Additional Manufacturer Narrative
The analysis was performed on a cobas 8800 analyzer (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 confirmed that the hbv target growth curve was robust and sigmoidal, indicative of true viral target amplification.The internal control, positive control targets, and negative control all demonstrated robust sigmoidal growth curves, confirming proper assay performance.The cycle threshold (ct) value of 36.8 suggested that the sample had a viral concentration near, at, or past the assay's limit of detection (lod), where wavering results between reactive and non-reactive may occur.The most likely cause of the discrepant result was attributed to the sample being an lod sample.Clinically, in the context of non-reactive serology, the donor is most likely a true hbv-positive donor with an occult blood infection (obi), where trace amounts of viral target may intermittently be present in the bloodstream.

• 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: 23100144
• Report Number: 2243471-2025-03279
• Device Sequence Number: 9224979
• Product Code: QHO
• UDI-Device Identifier: 00875197004779
• UDI-Public: 00875197004779
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 03/31/2023
• Device Catalogue Number: 06998917190
• Device Lot Number: H30627
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• 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