MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS; NUCLEIC-ACID TESTS FOR INFECTIOUS DISEASE SCREENING OF BLOOD & PLASMA DONATIONS

Catalog Number	07001070190
Medical Device Problem Codes	False Positive Result (1227); 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	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas 8800 analyzer (serial number: (b)(6)).The investigation determined that the cobas wnv assay was performing within specifications.A review of the target growth curves for the provided data showed sigmoidal amplification, indicating that true viral target was being amplified.Positive and internal controls were robust and sigmoidal, further confirming proper assay performance.The investigation was limited as the specific sample ids alleged to be false reactive were not provided.Without this information, a definitive root cause could not be determined.However, potential contributing factors for unexpected reactive results may include contamination due to deviations from optimal workflow during reagent or sample handling, or samples in the pool being at or near the assay's limit of detection.Non-specific amplification was ruled out based on the amplification curves.The device remains in operation at the customer site, and no further harm or delay in treatment was reported.
Event or Problem Description
The initial reporter alleged an increase in unexpected reactive results when using the kit cobas 6800/8800 wnv 480t ivd assay on the cobas 8800 instrument during the month of (b)(6) 2022.The customer¿s workflow involves testing samples in pools of 6 (b)(6).If a pool generates a reactive result for west nile virus (wnv), the samples are tested in resolution, and the results are non-reactive.The donations associated with these results were not rejected.The data provided by the customer included the following reactive samples with their respective cycle threshold (ct) values: (b)(6) (33.5), (b)(6) (36.7), (b)(6) (29.4), (b)(6) (28.0), (b)(6) (26.0), (b)(6) (25.8), (b)(6) (39.9), (b)(6) (38.3), (b)(6) (27.6), (b)(6) (24.4), (b)(6) (27.9), (b)(6) (34.2), (b)(6) (33.8), (b)(6) (38.7), and (b)(6) (39.1).The specific sample ids alleged to be false reactive were not provided.

• Brand Name: COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS
• Common Device Name: NUCLEIC-ACID TESTS FOR INFECTIOUS DISEASE SCREENING OF BLOOD & PLASMA DONATIONS
• 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: 23085571
• Report Number: 2243471-2025-03118
• Device Sequence Number: 15901665
• Product Code: QHO
• UDI-Device Identifier: 00875197004977
• UDI-Public: 00875197004977
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: BL125575
• 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): 09/18/2025

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: 07001070190
• Device Lot Number: H13573
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/18/2025
• 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