CARDIOCHEK PLUS ANALYZER

Additional Manufacturer Narrative

CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE MALFUNCTIONED, AS THE DEVICE WAS NOT RETURNED. 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.

Description of Event or Problem

THERE WERE NO ALLEGATIONS OF PATIENT OR USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. THE CONTACT CLAIMS THEIR CARDIOCHEK WAS " CONSIDERABLY HOT AND THERE WAS CORROSION IN THE BATTERY COMPARTMENT". BATTERIES DESCRIBED AS "LOOK LIKE THEY WERE ABOUT TO EXPLODE". THE CUSTOMER WAS USING THE REPORTED ANALYZER BEYOND IT'S RECOMMENDED LIFE AND THE REPORTED CORROSION IS ASSOCIATED WITH IMPROPER STORAGE OR HANDLING.