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 Positive Result (1227); 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	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analysis was performed on a cobas 6800 analyzer (serial number: (b)(6)).The investigation determined that the cobas wnv assay was performing within specifications.All reactive samples provided in the data exhibited robust, sigmoidal growth curves for the wnv target, which typically indicates true viral target amplification.The positive control for wnv also demonstrated robust and sigmoidal growth, confirming proper assay functionality.The alleged sample with a cycle threshold (ct) value of 38 was not provided by the customer despite multiple requests.As a result, the reported allegation could not be confirmed, and a definitive root cause could not be determined.Differences in assay sensitivity between the cobas wnv assay and the in-house pcr test may explain the discrepant results.The donation associated with the sample was not used, and no harm or delay in treatment was reported.
Event or Problem Description
The initial reporter alleged discrepant results when using the kit cobas 6800/8800 wnv 96t ivd assay on the cobas 6800 instrument.The customer reported that a pool of 8 samples was reactive for west nile virus (wnv).Upon resolution testing, the pool was reactive with a cycle threshold (ct) value of 38.An in-house polymerase chain reaction (pcr) test performed on the same sample was non-reactive.The donation associated with the sample was not used.

• 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: 23100162
• Report Number: 2243471-2025-03283
• Device Sequence Number: 9225457
• 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: 09/30/2023
• Device Catalogue Number: 07001061190
• Device Lot Number: H32785
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• 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