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

Catalog Number 700-3375

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and observed that the leak was from the evacuation pump where there were two connections that were loose.Fse tightened the connections to resolve this issue.Fse also stated that there was a leak at the connections from the waste well.The connections were tightened also to resolve the issue.The repairs were verified as per service procedures.(b)(4).

Event Description

The customer reported that there was a contained fluid leak on their iq 200 system.Customer was wearing personal protective equipment (ppe) consisting of gloves and a lab coat at the time of discovery.There was no direct exposure to wounds or mucous membranes as a result of this event.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.

• 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: 5978162
• MDR Text Key: 55678908
• Report Number: 2023446-2016-00369
• 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: 08/30/2016

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: 700-3375
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2011
• 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