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

Model Number U411

Device Problem Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The field service engineer (fse) cleaned the printed circuit board (pcb) test strip sensor.The sensor was tested and calibration and qc were run.The instrument worked well with no problem.The issue was not solved after the service visit.The fse then replaced test strip sensor 2.Following the replacement of test strip sensor 2, the issue was solved.The investigation determined the issue was a due to a problem with test strip sensor 2.

Event Description

The initial reporter alleged a possible patient sample mismatch on the cobas u 411 analyzer.The reporter alleged that in the work list, the last patient id is assigned to the current strip ready to be measured.This could cause an issue with the interpretation of patient results.The customer's normal process is to scan 10 sample ids (creating a work list); the sample ids are then assigned to each strip one by one as the process goes forward.The customer can see the ids disappearing from the work list as each strip is measured.The issue occurs when a new strip is entered and the sample id is not deleted.When this occurs, no error or alarm displays, the strip is just sent to the waste container.The customer reviews each sample id and makes sure it was assigned correctly and is deleted from the work list.If they notice that the sample id was not deleted, the sample is repeated.The issue is intermittent and doesn't always happen.

• Brand Name: COBAS U411 TEST SYSTEM
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 9787912
• MDR Text Key: 205340496
• Report Number: 1823260-2020-00638
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K093555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1