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 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

The customer initially believed that the error was due to a software update on the meter, new software version 5.71.The customer has 3 different meters all of which have the newest software version.Two of the meters, serial numbers not provided, show negative results for the same samples that when tested on meter serial number (b)(4) are positive.So the issue does not appear to be exclusive to meters with the new software version.The meter was inspected and everything was acceptable.The customer's handling was fine.Calibration results have been acceptable.Qc results have been acceptable.The meter and test strips have been requested for further investigation.The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of false-positive nitrite results for one patient's urine sample tested with chemstrip 10 ux urine test strips on urisys 1100 analyzer serial number (b)(4).The customer believed the error was due to a recent change to the meter software version.The initial nitrite result from the meter was positive, but upon visual inspection of the test strip, the nitrite result was negative.It was unknown if the result in question was reported outside of the laboratory.The chemstrip 10 ux urine test strip lot number was requested but was not provided.

Manufacturer Narrative

The customer returned the affected meter and one vial of chemstrip 10 ux urine test strips for investigation.Retention chemstrip 10 ux test strips, the customer¿s chemstrip 10 ux test strips and the affected meter were tested and showed no false positive results.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: 9152744
• MDR Text Key: 208853947
• Report Number: 1823260-2019-03566
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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?: Yes
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1