MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ200

Catalog Number 700-3375

Device Problems False Negative Result (1225); Device Operates Differently Than Expected (2913)

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

Event Date 02/18/2015

Event Type  malfunction  

Event Description

Customer reported negative qc failing and lamina leaking.

Manufacturer Narrative

Customer stated their instrument failed negative qc.An iris field service engineer (fse) found evidence of a leak at the top of the pipette and replaced the pipette assembly.The fse ran qc and observed normal operations.There were no reports of erroneous result generated or reported out and no injuries reported.

• Brand Name: IQ200
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 4632075
• MDR Text Key: 5572411
• Report Number: 2023446-2015-00057
• 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: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• 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
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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