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

Catalog Number 700-7177-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and observed bubbles in the tubing at the probe.The fse replaced the dosage fluidic system (dfs) to resolve the instrument issue.The repairs were verified per established service procedures.(b)(4).

Event Description

Customer reported that the ca control for bilirubin was failing (false negative) on their ichem velocity automated urine chemistry system.There were no reports of erroneous patient results being generated or reported out and there was no change or effect to patient treatment in connection to the event.

• Brand Name: ICHEM VELOCITY 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, CA 91311 ; 8185277379
• MDR Report Key: 6090561
• MDR Text Key: 59579801
• Report Number: 2023446-2016-00398
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• 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: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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