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

Model Number U1100

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

An issue with the translation of the operator id or patient id was alleged with the urisys 1100 analyzer.The issue occurred intermittently at several different sites across southern sweden and with at least 40 different urisys 1100 instruments.Refer to the attachment to the medwatch for all involved serial numbers.The analyzers use a barcode scanner connected to a moxa box and are sending the data to a third party middleware aqure data management system.After the user scanned an operator id or a patient id, in the aqure system it appeared one of the digits would be changed.The issue was only detectable in the middleware when the data did not match what was expected.For example, the correct operator id was "(b)(6)", but the aqure system showed the operator id as "(b)(6)".In this example, the aqure system would create a new user as a blank space followed by the five digits, thus losing traceability of who actually operated the device.There was no report of any incorrect result being reported to a person making a treatment decision due to an incorrect patient id.There was no report of any adverse event.An issue with the barcode scanner was ruled out because if the scanner read the wrong barcode, the analyzer would not let them log in.It was suspected there was an issue with the analyzer or the moxa box conversion of the serial data to the tcp/ip.As the issue was intermittent, the settings of the moxa box were believed to be correct.

Manufacturer Narrative

A specific root cause could not be determined.Most probably, there were electromagnetic interferences which caused the issue.This interference could have an impact on instrument, communication between instrument and moxa box, or between moxa box and host system.Product labeling states the instrument must not be placed closely to electromagnetic devices.

• 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: 6576774
• MDR Text Key: 75523487
• Report Number: 1823260-2017-01032
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 07/06/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/18/2017
• Supplement Dates Manufacturer Received: 04/27/2017
• Supplement Dates FDA Received: 07/06/2017
• 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