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. THE REPORTED DEVICE WAS BEING USED BEYOND IT'S 3-YEAR SHELF LIFE, AND SUBSEQUENT EXAMINATION OF THE RETURNED ANALYSER LED TO OBSERVATIONS CONSISTENT WITH DEVICE MISHANDLING.

Description of Event or Problem

THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THE CUSTOMER REPORTED THAT AFTER BATTERY INSTALLATION, THEIR DEVICE WAS"HOT TO THE TOUCH AND THE BATTERIES APPEARED TO BE MELTING.". THE REPORTED ANALYZER WAS BEING USED BEYOND IT'S STATED 3-YEAR SHELF LIFE.