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	07001061190
Medical Device Problem Codes	False Negative Result (1225); 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	08/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged they observed invalid results using the kit cobas 6800/8800 wnv 96t ivd assay on the cobas 6800 system.The customer used west nile virus (wnv) control material from helvetica health care (hhc), concentrated at 10,000 copies/ml, which they diluted to the desired concentration using fresh frozen plasma (ffp).The customer reported non-reactive results for some dilutions of the wnv quality control material, which were expected to be reactive as they were above the assay's limit of detection (lod) of 12.9 copies/ml (lineage 1).The customer did not accept an initial explanation that these results were near the lod of the assay.
Additional Manufacturer Narrative
The reported event occurred on a cobas 6800 system with serial number (b)(6).The investigation determined that the cobas wnv assay (lot g12494) performed within specifications.No systemic issues, non-conformances, or recent changes related to the product were identified.Data analysis indicated that the non-reactive results observed by the customer were likely influenced by a suboptimal sample matrix, potentially containing pcr inhibitors.This conclusion was supported by suppressed growth curves and variability in internal control performance for the customer's wnv quality control samples, which were not observed in roche-manufactured controls.The wnv source material used by the customer was identified as panels from zeptometrix, which have previously been associated with matrix-related performance issues in a separate case.Additionally, the use of fresh frozen plasma as a diluent may have introduced inhibitors, though this could not be confirmed.The investigation did not identify any contribution from the cobas wnv assay (lot g12494) to the reported non-reactive results.The device remains in operation at the customer site.

• 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: 23097845
• Report Number: 2243471-2025-03209
• Device Sequence Number: 9321311
• Product Code: QHO
• UDI-Device Identifier: 00875197004960
• UDI-Public: 00875197004960
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,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: 04/30/2022
• Device Catalogue Number: 07001061190
• Device Lot Number: G12949
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2020
• 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