MAUDE Adverse Event Report: ROCHE DIAGNOSTICS UREAL; 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	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).
Event or Problem Description
The initial reporter questioned the results of multiple patient samples tested for multiple assays on a cobas 6000 c (501) module.Discrepant results were provided for 1 patient sample tested for ureal.The initial result was 0 mg/dl.The repeat result was 55 mg/dl."some" of the samples were accompanied by data flags prompting the customer to repeat patient samples.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The field service engineer (fse) did not identify a cause for the event.The fse cleaned the sample line assembly and all mechanical instrument checks were acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: UREAL
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21276893
• Report Number: 1823260-2025-00295
• Device Sequence Number: 8533112
• Product Code: CDQ
• UDI-Device Identifier: 04015630920464
• UDI-Public: 04015630920464
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/04/2025

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 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): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/04/2025
• 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