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

Catalog Number 700-7177-001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Not Applicable (3189)

Event Date 05/21/2016

Event Type  malfunction  

Manufacturer Narrative

The cts asked the customer to power down the instrument and tighten the thumb screw on the syringe, which was loose; however, controls continued to fail.Service was dispatched.A field service engineer (fse) evaluated the instrument at the customer's site and observed air in the tubing and syringe.The fse replaced the rinse pump assembly, and the controls were run successfully.No alarms were generated to alert the customer of the air in the line.On (b)(6) 2016, the customer reported ca controls failing false negative bilirubin and false low specific gravity.The customer told cts when strips from the waste bin were examined that the first two pads appeared to be white and completely dry.The customer also stated many urines were resulting in "blue" for color.The customer confirmed that none of the blue results were released out of the lab; they were caught and corrected prior to being released out of the lab.Service was dispatched to the customer location.The fse observed air in the tubing, and found the syringe body was loose, which appeared to have caused the air in the tubing.The fse tightened the syringe and ensured air bubbles were not present in the tubing.The fse was able to run controls successfully.On (b)(6) the customer called to report air bubbles in the tubing again.Service was dispatched to the customer location.The fse observed a crack in the syringe pump.The fse replaced the syringe pump assembly to resolve the issue, and was able to pass controls successfully.The customer service history was reviewed and the customer has not called back to report of any recurrences.(b)(4).

Event Description

The customer reported that controls failed for color and specific gravity on an ichemvelocity automated urine chemistry system.The customer technical specialist (cts) advised the customer via telephone to perform a color gravity module (cgm) clean.The customer failed controls again upon repeat.The cts informed the customer that controls are only good once opened, for 15 days; the customer stated the controls were opened on (b)(6) 2016 and the controls had been opened for approximately 19 days.The cts advised the customer to open fresh controls.Upon repeat with the fresh controls, the customer reported failing ca false negative for bilirubin and blood; cb failing false negative for urobilinogen and false positive for blood, and the customer experienced low specific gravity for both ca and cb.Erroneous patient results were not generated and there was no injury or effect to patient treatment related to this event.This report refers to the event that occurred on the date of event; refer to 2023446-2016-00278 for report of the event that occurred on (b)(6) 2016 and 2023446-2016-00279 for the report of the event that occurred on (b)(6) 2016.

• 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: 5720782
• MDR Text Key: 47288915
• Report Number: 2023446-2016-00277
• 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: 05/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• 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: 05/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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