CARDIOCHEK PLUS ANALYZER

Additional Manufacturer Narrative

CURRENTLY IT IS UNKNOWN WHETHER 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. THE CUSTOMER REPORTED RESIDUE ON THE BATTERY TERMINAL OF THE REPORTED ANALYZER PRIOR TO THE REPORTED ISSUE OCCURRING. THE CUSTOMER REPORTED THAT "THE ANALYZER WAS WARM OR HOT TO TOUCH".