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

Model Number U1100

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 03/29/2016

Event Type  malfunction  

Event Description

The customer reported that they were receiving an e6 chip error on the urisys 1100 urine analyzer.During troubleshooting the instrument was powered off.The customer stated that the program chip looks like it is burned on the tip of the program chip.She stated the program chip did not feel hot to the touch.She stated the instrument had been powered off all night and had just been powered on a few minuted prior to calling.She stated just before the call she powered off the unit.She stated there were no other signs of burning/melting or smoking on the instrument itself.She stated there were no injuries related to the burnt program chip.The analyzer was requested to be returned and a replacement was sent.

Manufacturer Narrative

During the investigation, the e6 optics error was reproduced.When the device was disassembled, it was noted that the program chip was damaged and showed signs of oxidation and one of the four metal strips was blackened at the end.This is characteristic of the chip being short-circuited by a liquid being present.There was also a clearly visible liquid mark near the chip's socket.The root cause was determined to be that liquid got into the program chip's socket and caused the short-circuiting of the chip due to 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: 5590153
• MDR Text Key: 43166233
• Report Number: 1823260-2016-00457
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• 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: 03617556001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• 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