ICHEM VELOCITY
Received Dec 11, 2013 · Event occurred Sep 16, 2013
Report 2023446-2013-00043 · MDR key 3636176
Device
Product problems
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO PTS WERE HARMED OR TREATED ANY DIFFERENTLY DUE TO THIS PROBLEM. IRIS FSE REVIEWED SERVICED THE INSTRUMENT (I.E., ALIGNED THE PROBE), REVIEWED THE ERROR LOG AND PERFORMED THE VELOCITY PERFORMANCE CHECKLIST. UPON COMPLETION, CONTROLS WERE RAN AND WERE WITHIN SPECIFICATIONS. SYSTEM WAS DEEMED OPERATIONAL WITHOUT ANY FURTHER ISSUES.
Description of Event or Problem
CUSTOMER REPORTED THAT THE HOSPITAL'S VELOCITY ANALYZER THAT REPORTED NO BLOOD PRESSURE A FEW TIMES AND FEW TO MODERATE RBCS ON THE IQ200 FOR THE SAME PT. CUSTOMER STATED THAT AT NO TIME WERE ANY ERRONEOUS RESULTS REPORTED ON ANY PTS. NO PTS RECEIVED ANY DIFFERENT TREATMENT DUE TO THE FALSE NEGATIVE REPORT OF BLOOD OFF THE VELOCITY ANALYZER. THE PRESENCE OF WBCS WAS VERIFIED BY THE IQ200.