MalfunctionCDM
ICHEM VELOCITY
Received Apr 6, 2015 · Event occurred Mar 7, 2015
Report 2023446-2015-00116 · MDR key 4782118
Device
Generic name
Automated Urine Chemistry Analyzer
Manufacturer
Iris InternationalCatalog number
700-7177-001
Product problems
- False Negative Result
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER STATED THE CONTROLS ARE FAILING.
Additional Manufacturer Narrative
CUSTOMER REPORTED THE ICHEM VELOCITY FAILING CONTROLS. THERE WERE NO REPORTS OF PATIENT RESULTS BEING AFFECTED AND NO REPORTS OF CHANGE TO PATIENT MANAGEMENT AS A RESULT. AN IRIS FIELD SERVICE ENGINEER (FSE) REPLACED AND PERFORMED AN ALIGNMENT. THE FSE RAN QC WHICH PASSED. SYSTEM WAS OPERATIONAL.