MAUDE Adverse Event Report: BECKMAN COULTER ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM; AUTOMATED URINALYSIS SYSTEM

Model Number	2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING UP TESTED I
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fse found that the ground wire on the pipette bracket assembly was melted.The fse replaced the pipette bracket assembly to resolve the issue.Further information has been requested regarding the customer's burn; a supplemental report will be filed when additional information regarding the injury is known.
Event or Problem Description
The customer reported an exposed wire above the probe on an ichemvelocity system.The customer saw a puff of smoke and reported a charred area on the instrument.The customer informed the customer technical specialist (cts) that they attempted to perform their own troubleshooting.The customer reported on the initial call that there were no injuries.The field service engineer (fse) documented in the service record that the customer further reported that a ground wire on the pipette bracket assembly melted her glove and burned her finger.It is unknown at this time whether the customer required medical treatment for the burn.
Additional Manufacturer Narrative
Evaluation codes - conclusion code updated.The operator was performing a maintenance to the instrument.While releasing the sample probe, her index finger touched the wire on the sample probe and burnt their finger though their glove.No medical attention was needed.The operator filed a report with the occupational health department as required by their laboratory.The smoke observed was from the glove melting.The fire department was no called.There was no fire extinguisher used.The operator was wearing personal protective equipment (ppe) consisting of gloves and a lab coat.Bec internal identifier - (b)(4).

• Brand Name: ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM
• Common Device Name: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER; lismeehan; o'callaghan's mills, co clare ; EI
• MDR Report Key: 8923233
• Report Number: 2122870-2019-01113
• Device Sequence Number: 1962617
• Product Code: KQO
• UDI-Device Identifier: 10837461001751
• UDI-Public: (01)10837461001751(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K171083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: 2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING UP TESTED I
• Device Catalogue Number: 700-7177-001
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/23/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other