MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM; AUTOMATED URINALYSIS SYSTEM

Catalog Number	700-7177-001
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was at the customer site and observed that the syringe pump assembly was making a clicking noise, and found the syringe pump assembly was causing a minor pulse when it clicked causing a dosing issue.The dosing issue was occurring in the same proximity as the glucose and ketone pads on the strip.The fse replaced the syringe pump assembly and was able to run controls successfully.The repairs were verified per established service procedures.(b)(4).
Event or Problem Description
The customer reported that glucose was failing false negative for ca control on their ichem velocity urine chemistry system.There were no reports of erroneous patient results being generated or reported out and there was no change or effect to patient treatment in connection to the event.

• Brand Name: ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM
• Common Device Name: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• MDR Report Key: 6074865
• Report Number: 2023446-2016-00393
• Device Sequence Number: 16156950
• Product Code: KQO
• UDI-Device Identifier: 10837461001751
• UDI-Public: (01)10837461001751
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2016

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: Other Health Care Professional
• Device Catalogue Number: 700-7177-001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2016
• Initial Report FDA Received Date: 11/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1