MAUDE Adverse Event Report: BECKMAN COULTER ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number IQ200 ELITE 2008 TESTED

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

On 04-oct-2019, the field service engineer (fse) confirmed the reported issue and identified that the sata cable that connects to the cd-rom had failed/overheated.The fse removed the hard drive from the pc, cleaned the dust/debris from the area, ordered a new pc6, and scheduled a return visit.On (b)(6) 2019 and as part of work order (b)(4) the fse returned on-site and replaced the pc6 and installed the original hard drive that had been removed from the affected pc6.The affected computer was received by the product compliance engineering department in (b)(6) for further analysis.From the pc6 evaluation, it was confirmed that the reported cpu fire was due to an overheating of the dvd sata cable adapter.Investigation is ongoing.Internal bec identifier (b)(4).

Event Description

The customer reported that the central processing unit (cpu) on their iricell system caught fire.The iricell is composed of an ichem® velocity¿ automated urine chemistry system and an iq 200 urine analyzer.On (b)(6) 2019, the customer called customer technical support (cts) to report that their iricell system pc6 computer caught fire and smoke was emanating from it.The customer saw smoke coming from the pc and pulled the fire alarm.The fire department showed up and evacuated the laboratory.The customer confirmed that there was no injury to any laboratory personnel and that patient samples were not affected as a result of the alleged fire.There was no electrical hazard as a result of this event.There was no external fire hazard.No one was burned as a result of this event.

Manufacturer Narrative

Follow up 01: on october 05, 2019, the field service engineer (fse) had replaced the pc6 and installed the original hard drive with all the customer data, resolving the reported issue.The fse ran auto focus, iq controls, and velocity quality controls with all passing with no issues or errors being generated.All activities met the specified requirements and the system was left fully operational.On october 15, 2019, the affected computer was received by the product compliance engineering department at beckman coulter for further analysis.From the pc6 evaluation, it was confirmed that the reported cpu fire, was actually an overheating of the dvd sata cable adapter.Additionally, the following conclusions were documented on report #(b)(4): no electrical hazard occurred as a result of this event.No external fire hazard occurred as a result of this event.No burn hazard occurred as a result of this event.There was some potential for contact with smoke precipitated by this event.The level of impact to a user or anyone near the device would likely depend on their sensitivity to smoke or the acrid odor of burning electronics.Bec internal identifier - (b)(4).

Manufacturer Narrative

Follow up 02: section h7 - modification selected.Section h9 - correction/removal report number was added.On (b)(6)2020 , field action fa-000122 was initiated resulting in correction/removal report 2050012-03/25/2020-004c for this reported event.

• Brand Name: ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; lismeehan; o'callaghan's mills/co clare ; EI
• MDR Report Key: 9269691
• MDR Text Key: 172877030
• Report Number: 2122870-2019-01124
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 10837461001355
• UDI-Public: (01)10837461001355(11)NO-DATA
• Combination Product (y/n): N
• PMA/PMN Number: K171083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IQ200 ELITE 2008 TESTED
• Device Catalogue Number: 700-3375
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2020
• Removal/Correction Number: 2050012-03/25/2020-004C
• Patient Sequence Number: 1