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

Model Number U411

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that results were assigned to an incorrect sample when running samples on the cobas u 411 analyzer.Results for one sample were assigned to a different sample identifier.Error messages also appeared on the analyzer when this happened.The issue was resolved after the customer's laboratory information system was disconnected from the analyzer.

Manufacturer Narrative

No incorrect results were reported outside of the laboratory.The host was reconnected to the instrument and it is working without incident.No further information was provided.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: 9214169
• MDR Text Key: 205986917
• Report Number: 1823260-2019-03799
• 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
• Report Date: 12/03/2019

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: 10/02/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1