CARDIOCHEK PLUS ANALYZER

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.

Description of Event or Problem

THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. THE CUSTOMER REPORTED THAT THE REPORTED ANALYZER BECAME WARM TO TOUCH.