MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEMVELOCITY AUTOMATED URINE CHEMISTRY SYSTEM; AUTOMATED URINALYSIS SYSTEM

Catalog Number 700-7177-001

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was dispatched to the site to evaluate the instrument on 09/16/2016.The fse found a crack in the tubing from the color gravity module (cgm) to the probe.The fse replaced the tubing from the cgm to the probe to resolve the leak.The beckman coulter internal identifier for this report is (b)(6).

Event Description

The customer stated that there was a contained fluid leak of approximately 7ml from the probe on an ichemvelocity automated urine chemistry system.The customer was wearing personal protective equipment (ppe) consisting of gloves at the time of the event and there was no report of injury or biohazard exposure to open wounds or mucous membranes.Erroneous patient results were not generated and there was no injury or effect to patient treatment related to this event.

• Brand Name: ICHEMVELOCITY AUTOMATED URINE CHEMISTRY SYSTEM
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer (Section G): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 6000859
• MDR Text Key: 56495792
• Report Number: 2023446-2016-00380
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10837461001751
• UDI-Public: (01)10837461001751
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2016

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: 09/16/2016
• Initial Date FDA Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• 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