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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event involved the kit cobas 6800/8800 wnv 480t ivd assay on multiple cobas 8800 analyzers, including an analyzer with serial number (b)(6).The investigation determined that the cobas wnv assay and the cobas 8800 platform were performing within specifications.Data analysis indicated that the samples in question had a low viral load near or below the limit of detection (lod) of the cobas assay.This low viral load can result in variability between reactive and non-reactive results.A review of the reagent lots j19463 and j29998, as well as the control batch data, did not identify any product-related issues.No trends were observed in the complaint history for the reagent lots.The customer was advised to consider the reactive results for the samples in question, as these were confirmed in retesting.The investigation is considered closed, and no further actions are planned at this time.
Event or Problem Description
The initial reporter alleged discrepant results for two sample ids tested with the kit cobas 6800/8800 wnv 480t ivd assay on the cobas 8800 system.For sample id (b)(6), the following results were reported: on (b)(6)2023, the sample tested reactive on instrument 5091 with a target 1 cycle threshold (ct) value of 39.23 and an internal control (ic) ct value of 36.75.On (b)(6)2023, the sample tested non-reactive on instrument 5158 with no target 1 ct value and an ic ct value of 37.95.On (b)(6)2023, the sample tested non-reactive on instrument 5158 with no target 1 ct value and an ic ct value of 37.05.On (b)(6)2023, the sample, relabeled as (b)(6), tested reactive on instrument 5159 with a target 1 ct value of 38.15 and an ic ct value of 36.93.For sample id (b)(6), the following results were reported: on (b)(6)2023, the sample tested reactive on instrument 5091 with a target 1 ct value of 36.84 and an ic ct value of 36.38.On (b)(6)2023, the sample, pooled into pp6_mpx_wnv ((b)(6), tested non-reactive on instrument 5158 with no target 1 ct value and an ic ct value of 35.36.On (b)(6)2023, the sample tested non-reactive on instrument 5158 with no target 1 ct value and an ic ct value of 36.46.On (b)(6)2023, the sample tested reactive on instrument 5160 with a target 1 ct value of 37.64 and an ic ct value of 37.02.
Additional Manufacturer Narrative
H11 originally stated: "the reported event involved the kit cobas 6800/8800 wnv 480t ivd assay on multiple cobas 8800 analyzers, including an analyzer with serial number (b)(6).The investigation determined that the cobas wnv assay and the cobas 8800 platform were performing within specifications.Data analysis indicated that the samples in question had a low viral load near or below the limit of detection (lod) of the cobas assay.This low viral load can result in variability between reactive and non-reactive results.A review of the reagent lots j19463 and j29998, as well as the control batch data, did not identify any product-related issues.No trends were observed in the complaint history for the reagent lots.The customer was advised to consider the reactive results for the samples in question, as these were confirmed in retesting.The investigation is considered closed, and no further actions are planned at this time." h11 should be updated to say: "the reported event involved multiple cobas 8800 analyzers with serial numbers of (b)(6).Data analysis indicated that the samples in question had a low viral load near or below the limit of detection (lod) of the cobas wnv assay.This low viral load can result in variability between reactive and non-reactive results.A review of the reagent lots j19463 and j29998, as well as the control batch data, did not identify any product-related issues.No trends were observed in the complaint history for the reagent lots.The investigation determined that the cobas wnv assay and the cobas 8800 platform were performing within specifications.".

• 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: 23067545
• Report Number: 2243471-2025-02951
• Device Sequence Number: 13179456
• Product Code: QHO
• UDI-Device Identifier: 00875197004977
• UDI-Public: 00875197004977
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 10/16/2025

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: 12/31/2023
• Device Catalogue Number: 07001070190
• Device Lot Number: J19463
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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