MAUDE Adverse Event Report: ROCHE DIAGNOSTICS UREA/BUN; UREA NITROGEN TEST SYSTEM

Catalog Number	05171873190
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).The field service engineer replaced the cuvettes, which appeared to resolve the issue.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable urea/bun results from the cobas 8000 c702 module.Sample 1 initial result was 9.06 mmol/l the repeat results were 35.84 mmol/l and 35.72 mmol/l.On (b)(6) 2024, sample 2 initial result was 0.85 mmol/l.The repeat results were 14.61 mmol/l and 14.67 mmol/l.The final repeat results were believed correct and were reported outside of the laboratory.
Additional Manufacturer Narrative
The field service engineer found crystals formed on the cuvettes.The cuvettes were replaced and the cuvette surface was cleaned.Precision testing was performed and was within specifications.The investigation determined the issue was due to the humidity level in the lab which can cause crystals of ecotergent.The investigation did not identify a product problem.

• Brand Name: UREA/BUN
• Common Device Name: UREA NITROGEN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21217740
• Report Number: 1823260-2025-00208
• Device Sequence Number: 3568754
• Product Code: CDQ
• UDI-Device Identifier: 04015630925131
• UDI-Public: 04015630925131
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K972250
• 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
• Report Date (Section B): 02/04/2025

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: 06/30/2025
• Device Catalogue Number: 05171873190
• Device Lot Number: 832104
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/04/2025
• 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