CARDIOCHEK PLUS ANALYZER

Additional Manufacturer Narrative

UPON VISUAL INSPECTION OF THE BATTERY COMPARTMENT, CORROSION CONSISTENT WITH THE REPORTED IMPROPER STORAGE OF THE RETURNED ANALYZER WAS OBSERVED. PTS IS CONFIDENT THAT THIS DAMAGE OCCURRED POST-DISTRIBUTION, AS THERE ARE NO MANUFACTURING STEPS THAT WOULD CAUSE THIS TYPE OF DAMAGE. THE CUSTOMER ALLEGATION OF "BATTERIES EXPLODED INSIDE THE ANALYZER" WAS NOT OBSERVED DURING TESTING OF THE RETURNED ANALYZER. PROPER STORAGE AND HANDLING OF CARDIOCHEK ANALYZERS AS OUTLINED IN THE INCLUDED USER GUIDE WAS NOT FOLLOWED BY THE CUSTOMER, LEADING TO THE REPORTED MALFUNCTION, WHICH WAS NOT DUPLICATED DURING TESTING OF THE RETURNED ANALYZER BY THE MANUFACTURER(PTS DIAGNOSTICS).

Description of Event or Problem

THERE WERE NO ALLEGATIONS OF PATIENT OR USER HARM. THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION. THE CUSTOMER USED THE VERBIAGE "THE BATTERY EXPLODED INSIDE THE ANALYZER" TO DESCRIBE AN EVENT IN WHICH "THE PHARMACY WAS ATTEMPTING TO RUN ROUTINE QC ON ANALYZER TODAY WHICH WOULDN'T TURN ON SO THEY OPENED THE COMPARTMENT DOOR AND NOTICED THAT A BATTERY HAD SPLIT OPEN IN THE ANALYZER." THIS ANALYZER WAS BEING USED BEYOND IT'S RECOMMENDED DEVICE LIFE AND THE CUSTOMER REPORTED THAT THEY WERE NOT FOLLOWING PROPER STORAGE PROCEDURES FOUND IN THE USER GUIDE (PS-004561-EN REV 6), WHICH STATES THAT BATTERIES SHOULD BE REMOVED WHEN CARDIOCHEK ANALYZERS ARE NOT IN USE.