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); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with urea/bun (ureal) assay on a cobas 4000 c311 stand alone system.Initial result: 244 mg/dl (accompanied by a data flag).1st repeat result: 228 mg/dl (auto-repeated with dilution).2nd repeat result: 25 mg/dl.The 2nd repeat result was deemed to be correct.
Additional Manufacturer Narrative
The ureal reagent expiration date was not provided.The c311 stand alone system serial number was (b)((6).The field service engineer (fse) checked the instrument and found that the deionized water calibrator had been changed, causing an assay shift.He verified that the assay parameter was correct and the deionized water calibrator was correctly installed.The fse instructed the customer to load a new reagent pack and perform calibration.Afterward, calibration and qc were within specifications.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration was last performed on (b)(6) 2025, and it showed "std e" alarms.The qc recovery was within the customer's established ranges.There was no indication of a performance issue with the reagent.The centrifuge time was short, and the speed was high.The service actions performed by the field service engineer resolved the issue.No further issues were reported after the service visit.The investigation did not identify a product problem.The cause of the event was due to a user error where the deionized water calibrator had been changed, causing an assay shift.

• 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
• MDR Report Key: 22707790
• Report Number: 1823260-2025-02388
• Device Sequence Number: 15681413
• Product Code: CDQ
• UDI-Device Identifier: 04015630920464
• UDI-Public: 04015630920464
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 08/28/2025

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: 04460715190
• Device Lot Number: ASKU
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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