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

Catalog Number 700-3320

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 09/01/2014

Event Type  malfunction  

Event Description

Customer reported having intermittent flow errors, light fluctuation errors, and image acquisition errors.

Manufacturer Narrative

An intermittent flow errors, light fluctuation errors, and image acquisition errors were reported on the iq200 instrument.Fse checked the video image and light level.The video image looked good, but there was some every small flicker from the strobe bulb and the power level was also a little low.Fse replaced the strobe bulb to resolve the light fluctuation errors and replaced the camera to resolve the image acquisition errors, and replaced the flow cell to resolve the flow errors.Fse completed performance verification checklist.Customer ran multiple samples without any issues.System was operational.There were no reports of erroneous results generated for pt samples and no reports of change to pt management as a result.

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: 4272843
• MDR Text Key: 5298408
• Report Number: 2023446-2014-00165
• 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: 09/01/2014

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: 700-3320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2014
• Initial Date FDA Received: 10/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2006
• 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