MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U 411 URINE ANALYZER; AUTOMATED URINALYSIS SYSTEM

Catalog Number	04906969001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable false negative leucocyte results with the chemstrip 10 ua from the cobas u 411 urine analyzer for 6 samples.1 example was provided.The initial result was negative.During a manual microscopic run, it showed positive clusters of 50/100 clumps of white blood cell (wbc).The questionable results were not released outside of the laboratory.The microscopic reading of positive was deemed to be correct.
Additional Manufacturer Narrative
The chemstrip 10 ua lot numbers are 8379908 with an expiration date os 30-apr-2026.Lot 86099503, with an expiration date of 31-aug-2026, was used for troubleshooting purposes.Retention testing was completed and showed no false negative results, fulfilling the requirements.The investigation is ongoing.
Additional Manufacturer Narrative
The retention materials of lot 83799000 and lot 86099500, and the customer materials of lot 83799008 and 86099503 were measured on a cobas u411 analyzer with urine and a leucocytes-dilution-series.All used materials show no false negative results and fulfill our requirements.Per product labeling, "if the test is to be read visually, wait 60 seconds (60-120 seconds for the leukocyte test area) and then compare the reaction colors of the test areas with the colors on the label and assign always the values of the nearest color block.Any color changes appearing only along the edges of the test areas, or developing after more than 2 minutes, do not have any diagnostic significance." the investigation determined that no product issue could be found for the complained lots.

• Brand Name: COBAS U 411 URINE ANALYZER
• Common Device Name: AUTOMATED URINALYSIS 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23707779
• Report Number: 1823260-2025-04935
• Device Sequence Number: 21481711
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 04015630925636
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K093555
• 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): 12/22/2025

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: 04906969001
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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