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

Model Number U1100

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

A new test strip tray was sent to the reporter and upon installation of this new test strip tray on the urisys 1100 analyzer, no further issues with nitrite results were observed.This event occurred in (b)(6).

Event Description

The initial reporter stated they have been receiving false positive nitrite results for an unspecified number of patient samples tested using urisys 1100 analyzer serial number (b)(4).The issue started occurring after the urisys 1100 software was updated to version (b)(6).When an affected sample is run on a test strip on the urisys 1100 analyzer, the nitrite result will be positive.When visually reading the same test strip, no color change is visible on the nitrite test pad.The issue occurs with different patient urine samples.The lot number and expiration date of the test strips used on the analyzer were requested, but not provided.

Manufacturer Narrative

The test strips used on the analyzer were lot number 36255003 expiration date 31-jan-2020.

Manufacturer Narrative

The customer's urisys 1100 analyzer and one vial containing 52 of 100 tests strips of combur 10 ux lot 36255003 were provided for investigation.The analyzer and test strip tray were clean and did not show any damages.The test strip material showed no abnormalities.The retention material of lot 362550 and the customer material of lot 36255003 were both tested by visual reading with a nitrite dilution series and native urine.Additionally, the customer's urisys 1100 analyzer with software version 5.71 and test strip tray were measured with another strip lot #43065200 with native urine.Results: the retention material and the customer urisys 1100 analyzer with software version 5.71 and test strip tray showed no false positive results and fulfilled requirements.Medwatch fields d10 and h3 have been updated.

• 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: 9178521
• MDR Text Key: 218964810
• Report Number: 1823260-2019-03639
• 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,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1