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

Model Number U1100

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer replaced the test strip tray and the test strips but the issue continued.The customer stopped using the analyzer in question and is using a different one.The analyzer and test strips were requested for investigation.

Event Description

The initial reporter complained of false positive results for multiple patients tested for nitrites on the urisys 1100 analyzer since starting to use new software chip 5.71.The analyzer showed positive nitrite results but there is no visible color change on the test strips.The issue has occurred with urine samples from different patients.The combur 10 urine test strip lot number and expiration date were not provided.

Manufacturer Narrative

It was clarified that the erroneous results were generated with software version 5.61.The investigation is ongoing.

Manufacturer Narrative

The customer returned the instrument.The instrument was returned with no test strip tray.The device was clean and showed no damage.The customer's urisys 1100 analyzer ux09655789 was measured with another strip lot 43065200 with 0-native urine.The customer material showed no false positive results and fulfill the 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: 9403705
• MDR Text Key: 219764873
• Report Number: 1823260-2019-04221
• 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: 04/16/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 08/19/2019; 08/19/2019
• Supplement Dates FDA Received: 01/29/2020; 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1