MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY; AUTOMATED URINE CHEMISTRY ANALYZER

Catalog Number 700-7177-001

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

Event Date 04/12/2015

Event Type  malfunction  

Event Description

Customer stated their qc was failing and there was a leak on top of the spm.

Manufacturer Narrative

The customer stated their controls are failing and they found liquid on top of the strip provider module (spm) and in the waste bin.There are no reports of erroneous results generated or reported out of the lab.There are no reported injuries or exposure to the leak.Iris field service engineer (fse) was sent to the customer location and replaced tubing to resolve the leak.The fse re-ran controls and controls passed, the system was operational.

• Brand Name: ICHEM VELOCITY
• Type of Device: AUTOMATED URINE CHEMISTRY ANALYZER
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 4763466
• MDR Text Key: 5948596
• Report Number: 2023446-2015-00153
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101852
• 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: 04/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-7177-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2015
• 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