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 Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number was not provided.The investigation determined that the kit cobas 6800/8800 wnv 96t ivd assay performed within specifications, and no reagent contribution or product issue was identified.A review of the raw data confirmed that sample id: (b)(6) generated a reactive result with a cycle threshold (ct) value of 31.82, accompanied by a strong, sigmoidal amplification curve consistent with true target amplification and robust internal control amplification.The sample was positioned on the plate between the positive control and two higher titer specimens, which may have contributed to the observed result.The root cause was attributed to a high likelihood of contamination during sample preparation, accidental sample mix-up, or cross-contamination.The customer was advised to ensure adherence to good laboratory practices, including changing gloves between samples.
Event or Problem Description
The initial reporter alleged a discrepant result with the kit cobas 6800/8800 wnv 96t ivd assay during participation in the instand ringversuch 391 west nile virus (wnv) panel.The customer reported that one sample, identified as (b)(6), generated a reactive result with a cycle threshold (ct) value of 31.82, while the expected result provided by the panel was negative.

• 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: 23100572
• Report Number: 2243471-2025-03303
• Device Sequence Number: 8765907
• 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: 09/30/2024
• Device Catalogue Number: 07001061190
• Device Lot Number: J21199
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• 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