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

Model Number	U411
Medical Device Problem Code	Optical Obstruction (3002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The test strip sensor on the analyzer was cleaned, but the issue continued to occur.The customer shut off host communication on the analyzer and continued testing.
Event or Problem Description
The initial reporter stated there is a mismatch of patient data for one patient sample tested on the cobas u 411 analyzer.When manually running patient samples on the u 411, two test strips are tested sequentially on the analyzer without assigning a patient id to each test strip measurement.The first strip will not be read by the analyzer and then the results of the second strip are assigned to the patient/identifier of the first test strip.The customer provided data for one patient sample that was measured twice.The first measurement data was provided from the customer's host system as follows: color = yellow, density = 1015.000 (no units provided), ph = 9.0, nitrites = positive, leukocytes = 500.00 (no units provided), protein = 25.00 mg/dl, glucose = normal mg/dl, ketones = negative, urobilinogen = normal mg/dl, bilirubin = negative.The second measurement data was provided from a printout of the u 411 analyzer: density = 1.025 (no units provided), ph = 5, leukocytes = negative, nitrites = negative, protein = negative, glucose = normal, ketones = negative, uribilinogen = normal, bilirubin = negative, erythrocytes = negative.
Additional Manufacturer Narrative
An it specialist at the customer site reviewed host communication with the instrument.After his intervention, the issue did not reoccur.The issue was related to the customer's host system.

• 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: 15796058
• Report Number: 1823260-2022-03623
• Device Sequence Number: 3062162
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 04015630925636
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/05/2022

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
• Operator of Device: Health Professional
• Device Model Number: U411
• Device Catalogue Number: 04906969001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/05/2022
• 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