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

Catalog Number 700-7176-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); Irritation (1941)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

(age), and (weight) were not provided.The cause of the event is use error.The customer put her head inside the instrument and her eye made contact with the corner of the waste drawer.The customer was not wearing eye protection.The information available does not reasonably suggest there was an instrument malfunction.Per ichem velocity operator's manual 301-7146 na, rev bb, release date - 02/2017, "read all product manuals and consult with beckman coulter-trained personnel before attempting to operate instrument.Do not attempt to perform any procedure before carefully reading all instructions.Always follow product labeling and manufacturer's recommendations.If in doubt as to how to proceed in any situation, contact your beckman coulter representative." per ichem velocity operator's manual 301-7146 na, rev bb, release date - 02/2017, "risk of injury.Iris international urges its customers to comply with all national health and safety standards such as the use of barrier protection.This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire".(b)(4).

Event Description

The bci applications specialist reported during a training session at a customer site; the customer looked inside the 2.5 ichem velocity waste drawer and received an eye abrasion from the corner of the drawer.The customer stated she was not instructed to put her head inside the analyzer.However due to curiosity; she wanted to take a closer look inside the waste drawer.She was not wearing eye protection.The customer stated that upon putting her head inside the instrument; her eye made contact with the corner or the waste drawer and became irritated immediately.The customer went directly to the emergency room at her facility.She was checked by a physician and given a prescription eye ointment for the irritation.Following the emergency room visit, the customer returned to work.The next day ((b)(6) 2017); the customer stated the irritation was gone.However, she followed up with an eye doctor.There was no damage to her eye.She was instructed to continue to use the eye ointment until finished as a precaution and continue all normal activity.The customer filed down the corner of the waste drawer following 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 ave; chatsworth, CA 91311
• MDR Report Key: 6691110
• MDR Text Key: 79235495
• Report Number: 2023446-2017-00006
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10837461001737
• UDI-Public: (01)10837461001737(11)NO-DATA
• 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: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 700-7176-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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
• Patient Outcome(s): Required Intervention