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

Model Number	U411
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer exchanged the test strip tray and cleaned a test strip sensor.Two runs of patient samples were processed and these were processed correctly.H3 other text : na.
Event or Problem Description
The initial reporter stated they had an issue with mismatched data on the cobas u 411 urine analyzer.There appears to be some overlap of data as data measured from a first sample will be associated with a second sample.For example, sample a will run on the analyzer and results will be measured for this sample.Sample b is then run on the analyzer and no results will be measured.Sample c is then run on the analyzer and the results measured from sample b then appear for sample c.
Additional Manufacturer Narrative
A review of the alarm information from the analyzer determined there was a software error and a measurement inconsistency error.The remedy for both errors requires a re-start of the system.If this is not done, this can lead to a sample mismatch.The system data logs were not available, so it could not be determined if the system was re-started.The field service engineer re-installed the software, verified the test strip sensor area was clean.Calibration and controls were processed successfully and no further issues have arisen.The investigation determined the service actions resolved the issue.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16855055
• Report Number: 1823260-2023-01486
• Device Sequence Number: 20474146
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 04015630925636
• Combination Product (Y/N): N
• Initial Reporter Country: NU
• 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): 05/23/2023

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 Model Number: U411
• Device Catalogue Number: 04906969001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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