MAUDE Adverse Event Report: IRIS INT'L IQ200; AUTOMATED URINE MICROSCOPY ANALYZER

Catalog Number 700-3370

Device Problems Fluid/Blood Leak (1250); Low Test Results (2458); Device Operates Differently Than Expected (2913)

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

Event Date 03/29/2013

Event Type  malfunction  

Event Description

Customer received the instrument is leaking from a fitting above the probe.

Manufacturer Narrative

The customer stated the instrument is leaking from the green fitting at the top of the probe.There were no erroneous pt results generated or reported out of the lab.There was no exposure and no injuries associated with the leak.Iris field svc engineer was sent to the customer location and replaced pbv valve to resolve the issue.Controls were run and the controls were passing.The system was operational.

• Brand Name: IQ200
• Type of Device: AUTOMATED URINE MICROSCOPY ANALYZER
• Manufacturer (Section D): IRIS INT'L; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 4748985
• MDR Text Key: 18091036
• Report Number: 2023446-2015-00140
• 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: 03/29/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• 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: 03/29/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• 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