MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® 6800 SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	05524245001
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	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged that the cobas infinity transmitted incorrect patient results to the laboratory information system (lis).The issue occured due to an aborted 6800 run as the system could no longer dispose of clotted tips due to full clotted tip racks.Therefore, the samples on the run were invalidated with 35 oul^r22 messages including the u04 flag.However, the cobas infinity processed the messages/flag as results and 35 patient sample results were automatically reported as "negative" in the lis.Note, out of the 35 affected samples, 29 were later retested successfully and received valid negative results.Further details for the six samples were not provided.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The alleged behavior could not be reproduced in a test environment.The investigation determined that no software issue was found with the navify lab operations (nlo) as it behaved as configured and designed for the received messages with the u04 alarm and subsequent sending of results to the external host with disabled flags.The observed behavior was a result of the combined cobas 6800 instrument and nlo configuration.However, the exact reason the customer's system sent the messages remains unclear.A rule in nlo was implemented at the customer site that checks all results for flag u04 and if it occurs, a repeat run will be performed.Thus, invalid results with flag u04 won¿t be released to the customer's laboratory information system (lis), and prevent the issue from recurring again.
Additional Manufacturer Narrative
Medwatch fields d1, d2, d4, g1, and g4 were updated.

• Brand Name: COBAS® 6800 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 0457
• 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: 23244919
• Report Number: 1823260-2025-04099
• Device Sequence Number: 10251420
• Product Code: MZA
• UDI-Device Identifier: 04015630935406
• UDI-Public: 04015630935406
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: BK140196
• 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): 12/01/2025

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 Catalogue Number: 05524245001
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 11/12/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/10/2025; 12/01/2025
• 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