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

Model Number	U411
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem 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
• Common Device Name: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7910252
• Report Number: 1823260-2018-03303
• Device Sequence Number: 1937263
• Product Code: KQO
• UDI-Device Identifier: 04015630925636
• UDI-Public: 4015630925636
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K093555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: U411
• Device Catalogue Number: 04906969001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1