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

Model Number U411

Device Problem Delayed Program or Algorithm Execution (4034)

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

Event Date 11/28/2022

Event Type  malfunction  

Event Description

The initial reporter alleged there was a mismatch of patient data for an unspecified number of urine patient samples tested on the cobas u 411 urine analyzer.The software version of the analyzer is 3.3.3.0019.On (b)(6) 2022, the reporter observed that the results obtained did not match the id numbers.They then processed sample by sample.On (b)(6) 2022, the issue persisted.The reporter noted that when two samples were processed, two results come out but the first comes out with a different id in the indicated free sequence and the second comes out with the id of the sample that was entered first.The reporter used a worklist.

Manufacturer Narrative

The investigation determined that the issue cannot be confirmed based on the data submitted covering the date of the event.The customer reported using a worklist.Product labeling states "the test strip is allocated to the first sample on the list." it was confirmed that the analyzer is working correctly.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16052369
• MDR Text Key: 308354711
• Report Number: 1823260-2022-04184
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Report Date: 12/27/2022

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 Model Number: U411
• Device Catalogue Number: 04906969001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1