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

Model Number	U411
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in (b)(6).
Event or Problem Description
The customer alleged a possible patient sample mismatch on a cobas u 411 analyzer with an unspecified software version.The customer stated that there was a mismatch result between a patient id number and the test strip result because the instrument did not correctly match the sample with the work list.The customer realized the problem and reprocessed the patient sample.No incorrect results were delivered to the patient.There was no allegation of an adverse event.A field engineering specialist replaced the strip sensor and the display module.The cobas u411 software version was updated to version 3.3.3.The investigation is currently ongoing.
Additional Manufacturer Narrative
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: 7952741
• Report Number: 1823260-2018-03530
• Device Sequence Number: 19177730
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1