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

Catalog Number	04906969001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant negative results for 1 patient tested with the combur 10 test m urine test strip on a cobas u411 urine analyzer.The sample obtained a negative result when tested on the instrument.The leucocytes result from the urine test strip was 100 leucocytes/ l (checked by visual verification).The qc was performed and it also obtained negative results.
Additional Manufacturer Narrative
The cobas u411 urine analyzer serial number was (b)(6) the test strips were requested for investigation.One vial of combur 10 test m test strips lot number 74839702 was received for investigation.The retention material of lot number 74839700 and the customer material of lot number 74839702 were measured on a cobas u411 analyzer and were checked by visual reading with native urine, a leukocytes-dilution series, and biorad liquichek lv 2 number 98012 and the results were within specifications.The investigation is ongoing.
Additional Manufacturer Narrative
The customer did not provide any additional information for the investigation.The retention material of lot 755153 was measured on a cobas u411 analyzer at the investigation site with 0-native-urine, a leukocytes-dilution series, and biorad liquichek.The retention material of lot 755153, was checked by visual reading with 0-native-urine, a leukocytes-dilution series, and biorad liquichek.The results fulfill the requirements.No false negative results were observed.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 20028496
• Report Number: 1823260-2024-02423
• Device Sequence Number: 15601099
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 04015630925636
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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): 10/14/2024

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 Catalogue Number: 04906969001
• Device Lot Number: 75515304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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