MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® 8800 SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	05412722001
Medical Device Problem Codes	False Positive Result (1227); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable cobas® wnv (192t) assay result for a donor patient sample tested on a cobas 8800 analyzer.The initial result was reactive.The sample was repeated twice and the results were non-reactive both times.
Additional Manufacturer Narrative
The serial number of the cobas 8800 analyzer was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d1, d2, d4, g1, and g4 were updated.
Additional Manufacturer Narrative
A review of the provided raw data was performed, which revealed that the fluorescence curve for the wnv target channel showed an early amplification signal with a ct (critical threshold) value of 2.3 and a low rfi (relative fluorescence intensity) value of 2.2.This has been associated with the microgear pump pipetting issues, resulting in a false reactive result.

• Brand Name: COBAS® 8800 SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• 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 46250-0457 ; 9253534412
• MDR Report Key: 23488024
• Report Number: 2243471-2025-04533
• Device Sequence Number: 21472315
• Product Code: MZA
• UDI-Device Identifier: 04015630935390
• UDI-Public: 04015630935390
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: BK140195
• 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,Followup,Followup
• Report Date (Section B): 12/22/2025

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: 08/31/2026
• Device Catalogue Number: 05412722001
• Device Lot Number: N01087
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 12/16/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/12/2025; 12/22/2025
• 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