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

Catalog Number	04460715190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the provided calibration data, the reagent's lot number is 927815.The serial number for module 2 is (b)(6).The field service representative checked the gear pump, probes, and the sample handling.He performed checks and tests with acceptable results.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable urea/bun results for 1 patient sample on a cobas c 503 analytical unit.The sample's initial test only produced a data flag on another c 503 module (module 2).The sample was repeated on the alleged module (module 1), and the result was 17 mg/dl.The sample was repeated on module 2, and the result was 134 mg/dl.This result was believed to be correct.The sample was repeated because the result didn't correlate with the patient's creatinine result of 3.6 mg/dl.
Additional Manufacturer Narrative
The calibration and qc were acceptable.Although no root cause was identified, the issue appears to be resolved by the service actions.The investigation did not identify a product problem.

• 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: 24570204
• Report Number: 1823260-2026-00859
• Device Sequence Number: 12850707
• Product Code: CDQ
• UDI-Device Identifier: 04015630920464
• UDI-Public: 04015630920464
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/10/2026

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: 04460715190
• Device Lot Number: 927815
• 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: 02/14/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/11/2026
• 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