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 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

The urisys 1100 serial number (b)(4) was checked with qc and the results were acceptable.The event occurred in (b)(6).

Event Description

The customer complained of false positive nitrite results for multiple patient urine samples from two urisys 1100 urine analyzers after the software update.The urisys 1100 was using software 5.71.The nitrite results on the urisys 1100 were positive.The nitrite results with a visual reading were negative.The uricult results were negative.The qc was acceptable.The combur 10 test strip lot number was 39664803 with an expiration date of 31-jul-2020.

Manufacturer Narrative

Sections d10 and h3 were updated.The customer stated they received false positive nitrite results for any strip lot they used.The customer provided an additional combur 10 strip lot in use of 40396202.The expiration date was not provided.The customer returned combur 10 test strip lot number 40396202 and both instruments (ux09650522 and ux09629340).Combur 10 test strip lot number 39664803 will not be returned as the test strips were used up.The retention material of lot 39664800 was tested on a urisys 1800 and a cobas u411 at the investigation site with 0-native urine, a nitrite-dilution-series, a a ketone-dilution-series, a a erythrocytes-dilution-series and a leucocytes-dilution-series.Both of the returned instruments were tested with a different strip lot (43065200) using 0-native urine.The retention material and the customer material showed no false positive results and fulfilled testing requirements.The investigation is ongoing.

Manufacturer Narrative

The customer material of lot 40396202 and retention material of lot 40396200 were measured on a retention cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material 40396200 and customer material 40396202 were checked by visual reading with native urine and a nitrite dilution series.The retention material 39664800 was checked by visual reading with native urine and a nitrite dilution series.The retention material and the customer material showed no false positive results and fulfilled requirements.

• 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: 9167893
• MDR Text Key: 208865699
• Report Number: 1823260-2019-03630
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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: 10/22/2019
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1