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 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

The customer's urisys 1100 was checked with qc and the results were acceptable.The urisys 1100 was returned to the customer and the customer stated that the issue continued.The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable nitrite results for multiple 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 no color change.The customer used a different test strip tray but the customer received the same questionable results.The customer used a different urisys 1100 urine analyzer and the results were "ok".The combur 10 test strip lot number was 39664803 with an expiration date of 31-jul-2020.

Manufacturer Narrative

The customer returned the instrument and the test strips.Retention material of strip lot 39664800 was run on a cobas u411 and was visually checked with 0-native-urine, a erythrocytes-dilution-series and a nitrite-dilution-series.Retention material of strip lot 39664800 and the customer's test strips with lot 39664800 were both visually checked with 0-native-urine, a erythrocytes-dilution-series and a nitrite-dilution-series.The customer's instrument was tested using a different strip lot (43065200) with 0-native urine.The retention material and the customer material showed no false positive results and meet the requirements.The measurements showed no false positive results and showed no abnormalities.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: 9172740
• MDR Text Key: 217100138
• Report Number: 1823260-2019-03642
• 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: 01/21/2020

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: 10/11/2019
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1