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

Model Number U411

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of an issue with the test strip on a cobas u 411 analyzer with software version 3.2.0 that has been occurring 1-2 times per week for approximately 1 month.The test strip was pushed into the slot but was not detected by the "strip check" function performed by the analyzer so the customer inserted a 2nd test strip.Since the first test strip was not processed, there was a mismatch between patient results.The specific results were requested but have not been provided.There was no allegation that an adverse event occurred.No instrument alarms or flags were displayed when the test strip was not detected.The field service engineer (fse) visited the customer site and found that the "strip check" function was working fine but on rare occasions the test strip was not detected.There will be no alarm and the order list does not move forward, but the customer will insert a new test strip.The fse advised the customer to verify that the "strip check" occurs prior to inserting a new test strip.The fse noted during random testing that when the test strip was not detected, he noticed the test strip was not close enough to the "strip check" sensor.The fse thinks the issue is with the test strip transfer system and not the sensor.The fse replaced the test strip transfer and lubricated the transport mechanism.Investigations are ongoing.

Manufacturer Narrative

The issue has not recurred since the test strip transfer was changed.The investigation is ongoing.

Manufacturer Narrative

The investigation did 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: 8111513
• MDR Text Key: 129448305
• Report Number: 1823260-2018-04519
• Device Sequence Number: 1
• Product Code: KQO
• 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,Followup
• Report Date: 01/09/2019

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: 11/05/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 11/05/2018; 11/05/2018
• Supplement Dates FDA Received: 12/20/2018; 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1