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

Catalog Number 700-3370

Device Problem Device Stops Intermittently (1599)

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

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument.The fse found the evacuation bypass valve (ebv) was faulty.The fse replaced the ebv, which repaired the failing controls.The fse re-reran controls and the controls passed.The system was operational.(b)(4).

Event Description

The customer reported the positive control of the iq200 elite instrument was failing intermittently.The customer attempted to troubleshoot but the controls continued to fail.There were no erroneous patient results generated or reported out of the lab.

• Brand Name: IQ200
• Type of Device: AUTOMATED URINE MICROSCOPY ANALYZER
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-l23; miami, FL 33196 ; 3053802031
• MDR Report Key: 5361241
• MDR Text Key: 36249381
• Report Number: 2023446-2016-00012
• 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: 12/14/2015

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: 700-3370
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2012
• 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