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

Model Number U1100

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Initial reporter facility name - the full facility name was provided as "(b)(6).".

Event Description

The customer stated that the urisys 1100 analyzer had caught fire from the inside of the unit.No actual flames or smoke were seen coming from the unit.The customer wanted to start a measurement on the analyzer and before they started this, the issue was noticed.The customer did not know what happened and noticed a burned smell.No one was injured and there was no evacuation of laboratory personnel.It is unknown if there was contact with fluid inside the unit.Upon visual inspection of the device, it was noted that the unit was burned and deformed due to high temperatures around the printer.No adverse events occurred for this event.

Manufacturer Narrative

The customer has clarified that the instrument was positioned close to a water tap on the counter top.The customer noticed in the morning that water had entered the printer paper compartment.After a few hours into the afternoon, the instrument started to smell badly.There was a strong burnt smell and when the customer could no longer bear the odor, she took the power plug out of the socket.When the customer opened the paper compartment, the paper was partly black on the outsides.No one was hurt and there was no evidence of smoke or fire.The instrument has been provided for investigation and a first inspection shows traces of discolored housing around the printer.

Manufacturer Narrative

Upon investigation of the analyzer, it was found that there were traces of a significant amount of liquid in the device.The liquid got onto the printed circuit board and destroyed the thermoprinter's temperature controlling chip.Due to this, the printer overheated.The most probable root cause for this is an operator handling error.

• 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: 5670138
• MDR Text Key: 45635104
• Report Number: 1823260-2016-00670
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 07/18/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• 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: 05/12/2016
• 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