AU5800 CLINICAL CHEMISTRY ANALYZER
Received May 3, 2013 · Event occurred Apr 5, 2013
Report 9612296-2013-00059 · MDR key 3092973
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman CoulterModel number
AU5821-02Catalog number
A94912
Lot number
NA
Product problems
- Air Leak
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER ALLEGED OBTAINING INTERMITTENT LOW NA (SODIUM) RESULTS ON CELL #1 INVOLVING THE AU5800 CLINICAL CHEMISTRY ANALYZER. THE AU5800 HAS A DUAL ISE (ION SELECTIVE ELECTRODE) CONSISTING OF CELL #1 AND CELL #2 WHICH FUNCTIONS INDEPENDENTLY WITH THE EXCEPTION OF A COMMON SAMPLE DISPENSE. THE CUSTOMER STATED THAT "A FEW" PATIENT SAMPLES WERE IMPACTED BUT COULD NOT PROVIDE A DEFINITIVE NUMBER OF PATIENT RESULTS WHICH WERE AFFECTED. NO RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED OBSERVING AIR IN THE ISE LINES WHILE TROUBLESHOOTING.
Additional Manufacturer Narrative
A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND REPLACED THE ISE REFERENCE VALVE TO RID AIR BUBBLES IN THE ISE REFERENCE LINE. THE FSE INSPECTED THE ISE SYSTEM AND PROCEEDED TO REPLACE ISE TUBING LINE #5 AND THE SAMPLE D-POT WHEN THE FSE DISCOVERED A CHIP IN THE CUP. THE FSE COMPLETED THE ISE SYSTEM CHECK BY REMOVING AND CLEANING THE ISE FLOWCELL. THE INSTRUMENT WAS CALIBRATED AND PRIMED, AND QC (QUALITY CONTROL) WAS RUN FOLLOWING REPAIRS. QC RESULTS WERE WITHIN THE ESTABLISHED RANGES AND INSTRUMENT'S PERFORMANCE MET PUBLISHED SPECIFICATIONS. FAILURE MODE IS ATTRIBUTED TO A FAILED ISE REFERENCE VALVE.