CARDIOCHEK PLUS ANALYZER

Description of Event or Problem

THERE WERE NO ALLEGATIONS OF PATIENT OR USER HARM. THE CUSTOMER REPORTED THAT "WHILE TRYING TO TROUBLESHOOT, THE BATTERIES/BATTERY COMPARTMENT BECAME VERY HOT TO THE TOUCH."

Additional Manufacturer Narrative

CURRENTLY IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE MALFUNCTIONED, AS THE ALLEGATION COULD NOT BE DUPLICATED. IT IS KNOWN THAT IMPROPER INSERTION OF BATTERIES - IN ANY DEVICE - MAY RESULT IN OVERHEATING, BATTERY LEAKAGE, ETC., WHICH IS STATED IN THE LABELING OF MOST BATTERY MANUFACTURERS. THE REPORTED DEVICE WAS BEING USED BEYOND ITS' RECOMMENDED DEVICE LIFE. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION.