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 Patient Involvement (2645)

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer had returned their urisys 1100 analyzer because the printer paper burnt and the meter did not turn on any longer.The customer indicated that when trying to print from the instrument, the paper wouldn't feed through the printer roller and it became burnt.It is not known if the paper was being inserted correctly or not.The printer paper was burnt but no flame was produced.There was a piece of "heavily" burned paper that has since been discarded.No adverse event occurred.It was not necessary to evacuate the laboratory.During the preliminary investigation with the returned analyzer and power adapter, the instrument would not turn on.A power adapter used at the investigation site was used with the customer's analyzer and the instrument still would not turn on.A retention meter was plugged in with the customer returned power adapter and the retention meter turned on indicating there was no issue with the customer's returned adapter.The customer's returned analyzer makes a faint buzzing noise when turned on.There are also visible burn marks on the printer roller and melted plastic and burn marks near the printer area of the instrument.

Manufacturer Narrative

During further investigation, the device was disassembled.There were no signs of melting on the printer cover; however, the surrounding plastic of the printer roller was deformed.The strip holder of the device was contaminated.Traces of urine were found inside the device and the printed circuit board (pcb) was visibly damaged by it.The thermoprinter's temperature controlling chip was damaged along with other parts of the pcb.The liquid also caused the device to short circuit.Liquid (urine or a disinfectant) got into the device.It destroyed the pcb and most of it's components.Because the thermoprinter's temperature controlling chip was damaged, the printer overheated and the plastic melted.This issue is not related to a product quality issue.The most likely root cause is a user handling issue.Instructions on performing tests correctly and the appropriate cleaning of the device are addressed in product labeling.

• 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: 5787264
• MDR Text Key: 49397874
• Report Number: 1823260-2016-00896
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2016
• 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