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 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer stated that with a new test strip tray there were no false positive nitrite results.The customer did not test qc.The event occurred in (b)(6).

Event Description

The initial reporter complained of false positive nitrite results for patient urine samples from a urisys 1100 urine analyzer after the software update.The urisys 1100 was using software (b)(6).The nitrite results on the urisys 1100 were positive.The nitrite results with a visual reading were negative.The urine cultures and sediment results were negative.The combur 10 test strip lot number was 40396202 with an expiration date of 31-aug-2020.

Manufacturer Narrative

The investigation found that one test strip tray showed signs of contamination.The tray was installed on an urisys 1100 analyzer and was measured with retention product.The measurement showed no abnormalities.No false positive results were detected.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: 9217709
• MDR Text Key: 218993838
• Report Number: 1823260-2019-03810
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• 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?: No
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1