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

Catalog Number	04906969001
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of regarding an alleged sample mismatch on a cobas u 411 urine analyzer.Reportedly, the sample results were assigned to the wrong patient.The customer stated that a sample was scanned and not measured immediately.A second sample was then scanned and the result of the second sample was assigned to the first sample.No incorrect patient results were reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
No product problem was identified.It was determined that handling and proper knowledge of the workflow configuration by the operator is essential to avoid mismatch.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18374952
• Report Number: 1823260-2023-04156
• Device Sequence Number: 18070581
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 04015630925636
• Combination Product (Y/N): Y
• Initial Reporter Country: WZ
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: 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: 12/06/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/29/2024
• 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