AU5400 CLINICAL CHEMISTRY ANALYZER
Received Jun 4, 2014 · Event occurred May 12, 2014
Report 9612296-2014-00084 · MDR key 3846742
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman CoulterModel number
AU5400-30Catalog number
N1464600
Lot number
NA
Product problems
- Device Displays Incorrect Message
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE FOUND A RUSTY GROUNDING POINT AT THE BOTTOM OF THE ION SELECTIVE ELECTRODE (ISE) UNIT. THE FSE STATED THAT BECAUSE ISE UNIT WAS NOT GROUNDED, IT WOULD PICK UP EXTRANEOUS NOISE. THE FSE CLEANED THE GROUNDING POINT AND PERFORMED A PRECISION STUDY. THERE WERE NO FURTHER REPORTS OF ISSUES.
Description of Event or Problem
THE CUSTOMER REPORTED OBTAINING A POTASSIUM RESULT WITH AN EXCLAMATION POINT FLAG, "!", FOR ONE PATIENT ON AN AU5400 CLINICAL CHEMISTRY ANALYZER. THE FLAG INDICATES THE ANALYZER WAS UNABLE TO CALCULATE CONCENTRATION. THE PATIENT SAMPLE WAS RERUN AND A RESULT WAS OBTAINED WITHOUT FLAGS. THERE WERE NO PATIENT RESULTS RELEASED FROM THE LABORATORY AND THERE WAS NO CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.