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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected operator received medical care.The information available does not provide the extent of the injury.Investigation is currently in process as to the assignable cause for the injury and the impact to other operators.Investigation is ongoing.Bec internal identifier (b)(4).
Event or Problem Description
The customer has reported that one of their operators is suffering from a skin rash and upper respiratory complications that began shortly after beginning to operate their ichem® velocity¿ automated urine chemistry system.The operator did seek medical treatment.The customer also stated that there have been other operators affected in the past.
Additional Manufacturer Narrative
Follow up 01: h6 evaluation codes updated with information available.The available information does not reasonably suggest there was an instrument malfunction; however, it is known that thymol, a component used to make the iwash solution for the instrument, has a strong smell and exposure to it can cause adverse effects on users with sensitivity to this agent.A retrospective review of complaints was conducted going back eighteen (18) months, there have been six (6) cases related to incidents where customers have complaint about strong odor or smell coming from the iwash solution.For all the other related cases, no injury or medical intervention was reported.In addition to the review of the batch records for the iwash solution, and assessment of the instrument and the facility was done and no malfunction or non-conformance was identified.The customer was given the safety data sheets of all reagents used in the iricell system on april of 2019.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: 8746573
• Report Number: 2122870-2019-01090
• Device Sequence Number: 16516479
• Product Code: KQO
• UDI-Device Identifier: 10837461001751
• UDI-Public: (01)10837461001751(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other