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

Catalog Number 700-7177-001

Device Problem Leak/Splash (1354)

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

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and observed that the color gravity module (cgm) required replacement.The fse also found that the syringe pump assembly was also malfunctioning and not allowing for the completion of the cgm calibration.He replaced the cgm assembly, it's respective tubing, and the syringe pump assembly and was able to run the instrument without further issues.The repairs were verified per established service procedures.(b)(4).

Event Description

The customer reported that their ichem velocity automated urine chemistry system was leaking from the color gravity module (cgm).The leak consisted of only a few drops onto the strip provider module (spm).The customer was wearing personal protection equipment (ppe) consisting of a lab coat and gloves at the time of discovery.Medical attention was not sought, there was no direct exposure to open wounds or mucous membranes.Erroneous patient results were not 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: 6017908
• MDR Text Key: 57047177
• Report Number: 2023446-2016-00384
• 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: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• 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: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2013
• 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