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

Catalog Number 700-3370

Device Problems False Negative Result (1225); Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

Iris field service engineer was sent to the customer location and found the tubing between the sample filter and pipette bypass valve (pbv) damaged due to normal wear.The fse replaced the tubing to resolve the issue.The fse ran controls and they passed.The system was operational.(b)(4).

Event Description

The customer reported focus control failure on their iq200 instrument.The customer shut the instrument down and rebooted.The customer reran controls and the positive control failed.The customer did further troubleshooting with customer technical support (cts) and ran a cleaning rack on the instrument.The customer reran controls and focus failed.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: gopal mohanty ; 9172 eton avenue; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 5270473
• MDR Text Key: 32773170
• Report Number: 2023446-2015-00289
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• 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
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2010
• 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