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

Catalog Number	05171873190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas 8000 cobas c 701 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable urea/bun (ureal) results from urine patient samples tested on the cobas 8000 cobas c 701 module.The reporter provided the following examples of discrepant results: sample 1 the initial result was 4.31 g/l.The repeat result was 8.67 g/l.Sample 2 the initial result was 0.32 g/l.The repeat result was 7.74 g/l.Sample 3 the initial result was 6.54 g/l.The repeat result was 0.49 g/l.The reporter assumes the "worst-case results" were incorrect.
Additional Manufacturer Narrative
The data was requested for investigation but not provided.The issue was solved without specific actions.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20832431
• Report Number: 1823260-2024-03503
• Device Sequence Number: 15612934
• Product Code: CDQ
• UDI-Device Identifier: 04015630925131
• UDI-Public: 04015630925131
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/27/2024

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: 05171873190
• Device Lot Number: 813816
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/27/2024
• 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