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

Model Number U411

Device Problem False Negative Result (1225)

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

Event Date 06/17/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12136120
• MDR Text Key: 260514293
• Report Number: 1823260-2021-01966
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 04015630925636
• Combination Product (y/n): N
• PMA/PMN Number: K093555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: U411
• Device Catalogue Number: 04906969001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1