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

Catalog Number 700-7177-001

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

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

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and inspected the connectors for the color gravity module (cgm) tubing.The tubing on the right side of the cgm was loose.The fse tightened the connectors and there were no more leaks.The fse also switched the settings to primary (iris fully automated), entered the correct lot numbers for the strips and the controls, and re-ran qc with no issues.The repairs were verified per established service procedures.(b)(4).

Event Description

The customer reported that there was a contained fluid leak that consisted of a few drops of possible wash solution and urine on their ichem velocity automated urine chemistry system.The customer also reported that they are unable to get qc to run.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.The customer was wearing personal protective equipment (ppe), there was no direct exposure of mucous membranes.There was no injury or medical attention required.

• 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: 5946211
• MDR Text Key: 54561694
• Report Number: 2023446-2016-00362
• 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: 08/24/2016

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: 08/24/2016
• Initial Date FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• 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