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 Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event involved the kit cobas 6800/8800 wnv 480t ivd assay on multiple cobas 8800 analyzers with serial numbers: (b)(6).The investigation determined no product issue was identified.Data analysis indicated that the sample in question had a low viral load near or below the limit of detection (lod) of the cobas assay.A review of the reagent lot: m20088, as well as the quality control data, did not identify any product-related issues.No trends were observed in the complaint history for the reagent lot.
Event or Problem Description
The initial reporter alleged discrepant results for a single sample id tested three times with the kit cobas 6800/8800 wnv 480t ivd assay on the cobas 8800 system.For sample id: (b)(6), on (b)(6) 2025 the sample tested reactive on instrument 5160.For sample id: (b)(6), on (b)(6) 2025 the sample tested non-reactive on instrument 5159.For sample id: (b)(6), on (b)(6) 2025 the sample tested non-reactive on instrument 5158.

• 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 46250-0457 ; 9253534412
• MDR Report Key: 23083048
• Report Number: 2243471-2025-03088
• Device Sequence Number: 9812326
• Product Code: QHO
• UDI-Device Identifier: 00875197004977
• UDI-Public: 00875197004977
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 03/31/2026
• Device Catalogue Number: 07001070190
• Device Lot Number: M20088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2025
• 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