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

Catalog Number 04906969001

Device Problem Computer Operating System Problem (2898)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The investigation is ongoing.

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
• Type of Device: 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
• MDR Text Key: 331344627
• Report Number: 1823260-2023-04156
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 04015630925636
• Combination Product (y/n): Y
• Reporter Country Code: WZ
• PMA/PMN Number: K093555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 04906969001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1