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 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that are having issues with mismatched patient identifiers on two cobas u 411 analyzers (serial numbers (b)(4)).When scanning the barcode of patient samples, the identifiers printed by the analyzer are different.The issue occurred at least twice.With each analyzer, sample barcodes are scanned, "v" is pressed on the sample entry window of the system software, and then a test strip is placed on the tray.For u 411 serial number (b)(4), the reporter mentioned that they have tried re-setting the sequence number in the system software but the reset does not work.For both systems, the reporter mentioned that when processing a total of 10 patient samples, for example, 10 test strips are inserted into the analyzer, but not all results are printed.Some samples from the work list generated in the system software do not disappear.An error is encountered which states there was measurement inconsistency.The error message instructs the user to confirm the correct work list sequence and try again.

Manufacturer Narrative

For u 411 serial number (b)(4) the investigation could not reproduce error 95 and sample mismatch.The log files indicated the instrument was not restarted and the user continued to work on the instrument.For u 411 serial number (b)(4) the investigation found there were open items in the "sample list" and/or "work list".It is not possible to reset the sequence number if there are open items in the directories.Additionally, the investigation could not reproduce error 95 and sample mismatch for u 411 serial number (b)(4).The log files indicated the instrument was not restarted and the user continued to work on the instrument.The investigation did not identify a product problem.

• 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: 8888362
• MDR Text Key: 154165620
• Report Number: 1823260-2019-02970
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• 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
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1