MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 1100; AUTOMATED URINE ANALYZER

Model Number U1100

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter's product has been requested for investigation.This event occurred in (b)(6).

Event Description

The initial reporter stated that they were having issues with incorrectly positive test results for an unspecified number of patient samples tested with nitrite (nit) on a urisys 1100 analyzer.Upon visual reading of the test strips, the nit results were negative.The issue started occurring after installation of a new software chip on the analyzer, version 5.71.The customer provided data for three patient samples and all three had discrepant nit results.One of the three samples also had discrepant results for ph, leukocytes (leu), protein (pro), and erythrocytes (ery).Refer to the attachment for all patient data.The test strips did not appear bent or discolored.Combur 10 test strips with lot number 36255003 and expiration date 31-jan-2020 were used.Quality control measurements on the urisys 1100 were ok.

Manufacturer Narrative

The customer returned the affected urisys analyzer and one vial of the affected combur 10-test test strips.The investigation determined the test trip tray on the urisys was slightly contaminated.The retention material and the customer material showed no false positive results and fulfills manufacturer requirements.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: URISYS 1100
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9082326
• MDR Text Key: 206976082
• Report Number: 1823260-2019-03356
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• PMA/PMN Number: K033548
• 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: 01/21/2020

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: U1100
• Device Catalogue Number: 03617548001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1