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

Model Number IQ200 SELECT 2008 TESTED

Device Problem Leak/Splash (1354)

Patient Problem Eye Injury (1845)

Event Date 07/09/2021

Event Type  Injury  

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 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
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC; lismeehan; o¿callaghan¿s mills; county clare ; EI
• Manufacturer (Section G): BECKMAN COUTLER; 1000 lake hazeltine dr.; chaska MN 55318
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12292082
• MDR Text Key: 265546728
• Report Number: 2122870-2021-00121
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10837461001300
• UDI-Public: (01)10837461001300(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050235
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IQ200 SELECT 2008 TESTED
• Device Catalogue Number: 700-3345
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other