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 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable nitrite results for 3 patient urine samples from a urisys 1100 urine analyzer.The urisys 1100 was using software version 5.71.For the 3 patients, the nitrite results on the urisys 1100 were positive.The repeat nitrite results were negative.The combur 10 test strip lot number and expiration date were asked for but not provided.The customer stated that the issue occurs with different test strip lots.

Manufacturer Narrative

The statement "for the 3 patients the nitrite results on the urisys 1100 were positive.The repeat nitrite results were negative" should have been the following: for patient 1 on (b)(6) 2019, the initial nitrite result was positive and the repeat result was negative.For patient 2 on (b)(6) 2019, the initial nitrite result was positive and the repeat result was negative.For patient 3 on (b)(6) 2019, the initial nitrite result was positive and the repeat result was negative.

Manufacturer Narrative

The customer did not run qc.The strip lot in use by the customer was 39664803.The retention material of lot 39664800 was tested.The results of the measurements fulfill the requirements.No false positive results were observed.The customer's test strips were not available for investigation.The customer's meter was received for investigation.Retention material was tested on the returned meter and met the requirements.The investigation did not identify a product problem.The cause of the event could not be determined.Fields d10 and h3 were 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: 9172785
• MDR Text Key: 190522977
• Report Number: 1823260-2019-03643
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• 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: 10/24/2019
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1