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 Measurement (1383); 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	10/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant results for hepatitis c virus (hcv) using the kit cobas 6800/8800 mpx 480t us-ivd assay.On (b)(6) 2021, the customer tested a third-party proficiency panel.Three samples (samples (b)(6) were non-reactive for hcv, whereas the expected results were reactive.Sample (b)(6) and sample (b)(6) were diluted from a stock solution containing an hcv viral concentration of 500 iu/ml to a secondary stock solution of 100 iu/ml.Sample (b)(6) was derived from the secondary stock solution of 100 iu/ml and was further diluted to 25 iu/ml.Additionally, sample (b)(6) was reactive for hcv with a cycle threshold (ct) value of 36.5, but the expected result was non-reactive.It was stated that sample 5 contained negative plasma.The samples were provided to the customer pre-diluted and ready for testing, with no additional workflow required.The samples were stored as indicated in the instructions and were shipped on ice.No remaining sample was available for repeat testing, and no additional samples were requested for further testing.
Additional Manufacturer Narrative
The analyzer serial number was not provided.The investigation determined that the kit cobas 6800/8800 mpx 480t us-ivd assay performed within specifications.Data analysis confirmed that the assay demonstrated expected amplification for the hcv target in the positive control and other samples expected to be reactive for hcv.The internal controls, as well as the positive and negative controls for the batch, were valid.The discrepant results for samples (b)(6) were attributed to sample-specific issues, such as incorrect preparation, loss of stock solution integrity, or mislabeling by the third party providing the samples.A product issue was not identified, and the investigation concluded that the assay was functioning as intended.

• 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: 23062494
• Report Number: 2243471-2025-02889
• Device Sequence Number: 21328864
• 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: 12/31/2021
• Device Catalogue Number: 06998917190
• Device Lot Number: G10208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• 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