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

Catalog Number 700-3320

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site on (b)(4) 2016 and found the probe bypass valve (pbv) tubing to filter leaking air.The fse replaced the tubing to resolve the reported issue the repairs were verified per established service procedures.(b)(4).

Event Description

The customer reported that there was a focus failure and positive control failure on their iq 200 system.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: 5701997
• MDR Text Key: 46663792
• Report Number: 2023446-2016-00267
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-3320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2005
• 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