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

Model Number U411

Device Problem Optical Obstruction (3002)

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

Event Date 10/28/2022

Event Type  malfunction  

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 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.

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
• 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: 15796058
• MDR Text Key: 307561672
• Report Number: 1823260-2022-03623
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 04015630925636
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 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
• Device Operator: Health Professional
• Device Model Number: U411
• Device Catalogue Number: 04906969001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/05/2022
• 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