MAUDE Adverse Event Report: IRIS INT'L 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 05/01/2015

Event Type  malfunction  

Event Description

The customer stated there is a contained leak coming from tubing located between the probe and the color, clarity and specific gravity module (cgm).

Manufacturer Narrative

Customer reported the ichem velocity had a leak coming from the cgm tubing located between the probe and the cgm.There were no reported injuries, no one was exposed to the leak and no erroneous pt results were generated.Iris field svc engineer evaluated the instrument and replaced the tubing to resolve the leak.The fse ran controls which passed and system is operational.

• Brand Name: ICHEM VELOCITY
• Type of Device: AUTOMATED URINE CHEMISTRY 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: 4824174
• MDR Text Key: 5841672
• Report Number: 2023446-2015-00169
• 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: 05/01/2015

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: 700-7177-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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