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

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Burn(s) (1757)

Event Date 07/23/2019

Event Type  malfunction  

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 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.

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
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER; lismeehan; o'callaghan's mills, co clare ; EI
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine dr.; chaska MN 55318
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 8923233
• MDR Text Key: 158610230
• Report Number: 2122870-2019-01113
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10837461001751
• UDI-Public: (01)10837461001751(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/23/2019
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other