MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 1100; AUTOMATED URINE ANALYZER

Model Number U1100

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they are getting questionable results for an unspecified number of patient samples tested for leukocytes and nitrites on a urisys 1100 analyzer.It was stated that the results from the analyzer would be negative, but when comparing to a visual reading of the test strips, the leukocyte and nitrite results are positive.No specific results were provided.Of the two tests, the samples had erroneous results for leukocytes.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.The patients were not adversely affected.The lot number and expiration date of the used test strips were asked for, but not provided.The analyzer and test strips have been requested for investigation.The customer also stated that it takes a long time for them to download a list of users into the analyzer and the analyzer often needs to be reset.It was also stated that the touch screen of the analyzer sometimes responds to touch with the wrong selection.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Information required for the investigation was requested, but not provided.

• Brand Name: URISYS 1100
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5707043
• MDR Text Key: 46863956
• Report Number: 1823260-2016-00743
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1