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

Catalog Number 04906969001

Device Problem Incorrect Measurement (1383)

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

Event Date 07/12/2023

Event Type  malfunction  

Event Description

The initial reporter complained of a software issue with a cobas u 411 urine analyzer.The customer alleged the sequence number of the patient¿s sample was changed leading to a mismatch in patient results.The specific results were not provided.The customer reviewed the urine sediment from the test and performed a visual verification where the issue was identified.

Manufacturer Narrative

The u 411 analyzer serial number was (b)(6).The investigation is ongoing.

Manufacturer Narrative

The field application specialist (fas) confirmed that on the day of the event, there was an issue with the result sequence and the result transmission.No data or actual results were provided for the investigation.Based on other information provided, the investigation noted there were some instrument issues when placing the test strip onto the test strip tray.The field service engineer (fse) replaced the printed circuit boards (pcb) for the test strip detector and the strip check.After the service visit, the customer had no further issues.As no specific data was provided for the investigation, the cause of the event could not be determined.

• 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: 17494769
• MDR Text Key: 320760211
• Report Number: 1823260-2023-02572
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 04015630925636
• Combination Product (y/n): Y
• Reporter Country Code: CS
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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
• Date Manufacturer Received: 08/25/2023
• 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