MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM; AUTOMATED URINALYSIS SYSTEM

Model Number	IQ200 SELECT 2008 TESTED
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exposed operator washed out her eyes with water and proceeded to the emergency room where their lab is located.The physician prescribed antibiotics as a preventive measure and stated there was no major injury.The operator was back at work the next day without issue and stated she is doing fine.Per iris system cleanser material safety data sheet (doc #(b)(4)) for reagent exposure section 16, the safety rating for physical contact is 3.Per beckman coulter product safety reference, item 14a, the rating equivalency for contact = 3 is medically reversible injury.Bec internal identifier case-(b)(4).
Event or Problem Description
The customer reported that while handling the cleanser bottle on their iq200 urine analyzer, the bottle hit the counter and cleanser fluid splashed in the operator's eye.The operator followed up with their er physician.The operator was wearing a lab coat and gloves at the time of the eye exposure and works with the instrument and cleaner on a daily basis.There were no erroneous results or patient impact as a result of this event, this was an operator injury.The physician prescribed antibiotics as a preventive measure and stated there was no major injury.The operator was back at work the next day without issue and stated she is doing fine.

• Brand Name: ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM
• Common Device Name: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC; lismeehan; o¿callaghan¿s mills; county clare ; EI
• MDR Report Key: 12292082
• Report Number: 2122870-2021-00121
• Device Sequence Number: 3180886
• Product Code: KQO
• UDI-Device Identifier: 10837461001300
• UDI-Public: (01)10837461001300(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K050235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: IQ200 SELECT 2008 TESTED
• Device Catalogue Number: 700-3345
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other