MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U411 TEST SYSTEM; AUTOMATED URINALYSIS SYSTEM

Model Number	U411
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated that an unspecified number of patient samples showed leukocyte results from the u 411 analyzer that were different from values observed upon microscopic evaluation of the samples.Results were manually edited on the u 411 analyzer to 100/ul or 500/ul.An example was provided for one patient sample which had discrepant leukocyte results.No incorrect results were reported outside of the laboratory.The sample initially resulted in an unknown value for leukocytes, but this value was likely negative.Microscopic evaluation of the sample determined it contains 21-30 lukocytes/hpf.The result on the analyzer was edited to 500/ul.The test strip lot number and expiration date were requested, but not provided.
Additional Manufacturer Narrative
As calibration and controls passed, an instrument issue is not suspected.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS U411 TEST SYSTEM
• Common Device Name: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12136120
• Report Number: 1823260-2021-01966
• Device Sequence Number: 17313188
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 04015630925636
• Combination Product (Y/N): N
• PMA/510(K) Number: K093555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1