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

Model Number IQ200 SELECT 2008 TESTED

Device Problems Fire (1245); Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

Event Type  malfunction  

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 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
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; caska, MN 55318 ; 9523681224
• MDR Report Key: 12408852
• MDR Text Key: 269381038
• Report Number: 2122870-2021-00134
• 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: FR
• PMA/PMN Number: K022774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 08/02/2021
• 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
• Removal/Correction Number: 2050012-03/25/2020-004C
• Patient Sequence Number: 1