MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ200; AUTOMATED URINE MICROSCOPY ANALYZER

Catalog Number 700-3320

Device Problems Charred (1086); Device Emits Odor (1425); Device Inoperable (1663)

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

Event Date 12/16/2012

Event Type  malfunction  

Event Description

Customer reported a burning smell from the iq200 unit.

Manufacturer Narrative

Customer reported burning smell coming from the iq200.Fse determined that the vertical motor on the spa had burned out.Fse replaced and calibrated spa and completed iq performance verification checklist.Customer ran specimens without any issues.System was operational.There were no reports of injuries, smoke emission, visible flames, and fire department was not called.

• Brand Name: IQ200
• Type of Device: AUTOMATED URINE MICROSCOPY ANALYZER
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277272
• MDR Report Key: 4272811
• MDR Text Key: 5031831
• Report Number: 2023446-2014-00161
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• 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: 12/16/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2004
• 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