MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ 200 SYSTEM; AUTOMATED URINALYSIS SYSTEM

Catalog Number 700-3322

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and observed that the source of the leak was the lamina bypass valve (lbv).The fse replaced the lbv and then primed the system 10 times and did not see any more leakage.The fse also an focus and it passed and ran qc twice and both times passed as well.The repairs were verified as per service procedures.(b)(4).

Event Description

The customer reported that there was an uncontained fluid leak of about 10ml coming from their iq 200 system.Customer was wearing personal protective equipment (ppe) at the time of leak discovery.There was no direct exposure to the leak.There were no erroneous patient results generated.There was no change to patient treatment.

• Brand Name: IQ 200 SYSTEM
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer (Section G): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth, ca, CA 91311 ; 8185277379
• MDR Report Key: 6091608
• MDR Text Key: 59579680
• Report Number: 2023446-2016-00400
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

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 Catalogue Number: 700-3322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1