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

Catalog Number	05171873190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).The field service engineer (fse) performed instrument decontamination, and the issue was resolved.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant low results for 2 patient samples tested for urea/bun on a cobas 8000 c702 module.Patient 1 initial result was 3.6 mg/dl.On (b)(6) 2025, the repeat result was 13.2 mg/dl.Patient 2 initial result was 1.4 mg/dl.On (b)(6) 2025, the repeat result was 34.7 mg/dl.
Additional Manufacturer Narrative
The investigation determined that the service actions resolved the issue.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23293546
• Report Number: 1823260-2025-04189
• Device Sequence Number: 10027557
• Product Code: CDQ
• UDI-Device Identifier: 04015630925131
• UDI-Public: 04015630925131
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/21/2025

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: 01/31/2026
• Device Catalogue Number: 05171873190
• Device Lot Number: 867715
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/21/2025
• 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