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 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer alleged a possible patient sample mismatch on the cobas u 411 analyzer with software version 3.3.3.The customer stated there are some instances where patient samples were processed by the analyzer but the patient has been deleted from the work list with no results produced for those patients.The customer thinks the results for the affected patients may have been assigned to other patients.The customer was unable to provide any specific results or patient data.There was no allegation that an adverse event occurred.The field service representative (fsr) visited the customer site and reloaded software version 3.3.3 and replaced the display module.The customer continued to have the issue.The customer provided the instrument database and error log for investigation.According to the data provided, the instrument works as specified and no abnormal behavior was identified.Additional information was requested from the customer for the investigation, however, no additional information could be provided.The customer stated the instrument is currently working fine.With insufficient information from the customer, the root cause could not be determined.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
• 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: 7910252
• MDR Text Key: 121870536
• Report Number: 1823260-2018-03303
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 4015630925636
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 09/26/2018
• 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