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 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

The retention material of lot 39664800 was measured on an iu cobas u411 with 0-native-urine, a nitrite-dilution-series, an erythrocytes-dilution-series, a ketone-dilution-series and a leucocytes-dilution-series.The measurements showed no false-positive results and showed no abnormalities.The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of false-positive nitrite results for an unspecified number of patient's urine samples tested with chemstrip 10 ux urine test strips on a urisys 1100 analyzer serial number (b)(4).The customer initially believed that the error was due to a software update on the meter, new software version 5.71.The initial nitrite result from the meter was positive, but upon visual inspection of the test strip, the nitrite result was negative.The results in question were not reported outside of the laboratory.The chemstrip 10 ux urine test strip lot number was 39664803 with an expiration date of 31-jul-2020.The customer stated that they have had the same problem with other lots of test strips, but no other specific lot numbers were provided.

Manufacturer Narrative

The instrument and test strips were received for investigation.Sections d10 and h3 were updated.The test strips showed no abnormalities.The customer's instrument ((b)(6)) was tested with 0-native urine with test strip lot 43065200 and false positive nitrite results were received.The instrument was opened and was slightly dirty inside the instrument, at the entry slot for the test tray and at the measurement unit.The instrument's led intensity was checked.No issues were identified.The investigation determined the malfunction is consistent with the contamination inside the instrument.

• 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: 9196138
• MDR Text Key: 219397209
• Report Number: 1823260-2019-03742
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• 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: 10/18/2019
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1