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	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	11/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant results with the kit cobas 6800/8800 wnv 480t ivd on the cobas 8800 instrument.The allegation involves a pooled sample that generated a reactive result for west nile virus (wnv).Subsequent individual donor testing (idt) of all samples within the pool generated non-reactive results.The non-reactive results were reported.The customer does not know if the blood was used.The samples in the alleged pool were collected between (b)(6) 2021 and (b)(6) 2021, with testing performed on (b)(6) 2021.
Additional Manufacturer Narrative
The analysis was performed on a cobas 8800 analyzer (serial number: (b)(6)).The investigation did not identify a product issue related to the customer complaint.Run logs and amplification curves were not provided, which limited the investigation.A review of the available information suggested the possibility of a false reactive result in the pooled run due to non-specific amplification.Additionally, the presence of a low titer sample near the limit of detection (lod) for the test could not be ruled out.Near the lod, sample results may vary upon retesting.A definitive root cause for the reported event could not be determined based on the available information.

• 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: 23083405
• Report Number: 2243471-2025-03098
• Device Sequence Number: 17330719
• 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 Catalogue Number: 07001070190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• 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