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 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The customer complained of false positive nitrite results for multiple patient urine samples from the urisys 1100 urine analyzer after the software update.The nitrite results on the urisys 1100 were positive.The nitrite results with a visual reading were negative.The physician tested his own urine twice on different days and the nitrite results on the urisys 1100 were positive.The nitrite results with a visual reading were negative.The qc was acceptable.The combur test strip lot number was 38055301.The expiration date was asked for but not provided.

Manufacturer Narrative

The customer's meter was provided for investigation.The device is clean and showed no damages.The retention material of lot 38055300 was measured on an retention urisys 1800 / cobas u411 with native urine and a nitrite dilution series and checked by visual reading.Additionally, the customer's urisys 1100 analyzer was measured with another strip lot (43065200) with native urine.The retention material and the customer material showed no false positive results and fulfilled requirements.Medwatch fields d10 and h3 have been updated.

Manufacturer Narrative

Medwatch field b1 was 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: 9162528
• MDR Text Key: 217088043
• Report Number: 1823260-2019-03596
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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: 10/18/2019
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR