MAUDE Adverse Event Report: ROCHE DIAGNOSTICS UREA/BUN; UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN

Catalog Number	04460715190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for approximately six patient samples tested with urea/bun on a cobas 8000 c 502 module.The customer provided an example of one patient sample with discrepant bun results.The sample initially resulted in a bun value of 3 mg/dl.The sample was repeated on a second analyzer, resulting in a bun value of 57 mg/dl.The repeat value was deemed correct and a corrected report was issued.
Additional Manufacturer Narrative
The bun reagent lot number was 84448001, with an expiration date of 31-aug-2025.The investigation is ongoing.
Additional Manufacturer Narrative
The customer cleaned the sample probe and performed air purges on the sample probe since a number of sample clot alarms occurred.The customer put a new reagent pack on the analyzer, then ran calibration and controls.No further issues were reported by the customer.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• Brand Name: UREA/BUN
• Common Device Name: UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN
• 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 46250-0457
• MDR Report Key: 21838902
• Report Number: 1823260-2025-01128
• Device Sequence Number: 7851869
• Product Code: CDQ
• UDI-Device Identifier: 04015630920464
• UDI-Public: 04015630920464
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 08/31/2025
• Device Catalogue Number: 04460715190
• Device Lot Number: 84448001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/14/2025
• 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 Age: 65 YR
• Patient Sex: Female