MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. IQ 200 URINE ANALYZER; AUTOMATED URINALYSIS SYSTEM

Model Number	IQ200 SELECT 2008 TESTED
Medical Device Problem Codes	Fire (1245); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) inspected the instrument and found the dvd rw's power plug was burnt, showing charring and a melted/burnt connector on the sata port of the dvd-rw.To resolve the issue a dvd rw replacement was ordered.The cause of the failure can be attributed to the dvd rw cable.The root cause was attributed to dielectric breakdown of the cable's molding.An image was provided on august 13, 2021 for the pc6 serial number.The serial number shown is (b)(4).This serial number was verified and found listed as part of cat 1 mod 12500 as a correction per (b)(4) ((b)(4) (fda recall id: z-1944-2020 and z-1945-2020)) for pc6 sata adapter cable.The mod completion is scheduled for november 6, 2021.Bec internal identifier (b)(4).
Event or Problem Description
The customer reported that the computer on their iq 200 urine analyzer generated a spark and blew the fuses of the laboratory.The dvd rw's power plug was burnt, showing charring and a melted/burnt connector on the sata port.There was no report of death, injury, or change to patient treatment as a result of this event.There was visible smoke observed.A fire extinguisher was not used.The fire department was not called and the lab as not evacuated.

• Brand Name: IQ 200 URINE ANALYZER
• Common Device Name: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• MDR Report Key: 12408852
• Report Number: 2122870-2021-00134
• Device Sequence Number: 14367799
• Product Code: KQO
• UDI-Device Identifier: 10837461001300
• UDI-Public: (01)10837461001300(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K022774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Notification,Inspection,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 08/02/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2050012-03/25/2020-004C
• Patient Sequence Number: 1