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U.S. Department of Health and Human Services

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

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IRIS INTERNATIONAL ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM; AUTOMATED URINALYSIS SYSTEM, Back to Search Results
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.
 
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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 Key6691110
MDR Text Key79235495
Report Number2023446-2017-00006
Device Sequence Number1
Product Code KQO
UDI-Device Identifier10837461001737
UDI-Public(01)10837461001737(11)NO-DATA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101852
Number of Events Reported1
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 Number700-7176-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/06/2017
Initial Date FDA Received07/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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