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	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas 8800 system (serial number: (b)(6)).The investigation determined that the cobas wnv assay performed within specifications, and no product or hardware issue was identified with the cobas wnv lots k21541 or m01062.A review of the provided data revealed weak wnv pcr curves with late cycle threshold (ct) values, while the internal control (ic) curves were robust.The observed variability between reactive and non-reactive results is most likely attributable to a very low viral load, near or below the test's limit of detection (lod).This is consistent with the expected variability in reactivity rates for low viral load samples, as outlined in the assay's instructions for use (ifu).The device remains in operation at the customer site, and no further issues have been reported.
Event or Problem Description
The initial reporter alleged discrepant results with the kit cobas 6800/8800 wnv 480t ivd assay on the cobas 8800 system.The allegation involves multiple west nile virus (wnv) samples that initially tested reactive but turned non-reactive upon retesting.Data provided by the customer showed weak wnv polymerase chain reaction (pcr) curves with late cycle threshold (ct) values, while the internal control (ic) curves were robust.Specific examples include: - sample id (b)(6): wnv curve 39.11, ic curve 34.76.- sample id (b)(6): wnv curve 39.53, ic curve 35.78.- sample id (b)(6): wnv curve 38.47, ic curve 34.62.- sample id (b)(6): wnv curve 39.19, ic curve 35.1.- sample id (b)(6): wnv curve 39.35, ic curve 35.15.The results were questioned due to the observed variability between reactive and non-reactive outcomes for the same samples.

• 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: 23099626
• Report Number: 2243471-2025-03259
• Device Sequence Number: 8765870
• 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): 09/19/2025

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: 10/31/2025
• Device Catalogue Number: 07001070190
• Device Lot Number: M01062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• 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