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

Catalog Number 700-3347

Device Problems Device Operates Differently Than Expected (2913); Optical Distortion (3000)

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

Event Date 09/07/2014

Event Type  malfunction  

Event Description

Customer reported having issue with iq200 images being gray and out of focus.

Manufacturer Narrative

Customer reported issues with iq200 micro images being gray and out of focus.While viewing video, which initially appeared normal, fse observed the video average dropped to 127 from 210 (light level dropping), making images dark.Fse replaced the camera and strobe power sic pcb, performed collimation and tilt adjustment.Fse followed-up with customer and verified that system was operating.No indications that pt results were reported out of lab.No change to pt management and no reports of erroneous urine cells or sediment.As per technical sme, there is a possibility of cells to be either placed in the unclassified section, which upon auto-release of results to the ljs, may not reach the physician, or mis-classification of cells resulting in either false positive or false negative rbc and/or wbcs.

Manufacturer Narrative

A subject matter expert assisted in the root cause of light fluctuation on the iq200 instrument.The sme stated, a light fluctuation or image error is a flagged sample on the instrument work list.A flagged sample on the instrument work list cannot be released automatically to the lis per iq200 ifu, iq200 series operators manual page 149 p/n: 3004320 rev.C release date: 07/2012.Therefore the risk control with this error could not lead to any patient harm.

• 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: 4272827
• MDR Text Key: 20457741
• Report Number: 2023446-2014-00155
• 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,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2014

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: 700-3347
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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