CARDIOCHEK PLUS ANALYZER

Additional Manufacturer Narrative

DURING THE INVESTIGATION, IT IS DETERMINED THAT THE TERMINAL DISPLACEMENT IS MOST LIKELY CAUSED BY THE CUSTOMER PROVIDING UNDUE FORCE ONTO THE BATTERY TERMINALS. IN ADDITION, THE POTENTIAL EXISTS FOR THE BATTERY CONTACT TO LOSE TRACTION WITH THE COMPARTMENT CAUSING LESS FORCE TO DISLODGE HOWEVER IMPROPER REMOVAL OF BATTERIES WILL STILL FORCE THE DISLODGE. SEVERAL KEY FACTORS POINT TO THIS DECISION: 1. THE BATTERY TERMINALS WOULD HAVE TO HAVE BEEN PROPERLY SEATED AT THE TIME OF MANUFACTURING BECAUSE THE ANALYZER WOULD NOT POWER ON AND WOULD CONSEQUENTLY BE UNABLE TO BE CALIBRATED AND RELEASED. 2. UPON CLOSE INSPECTION OF THE BATTERY TERMINAL AREA, IT WAS OBSERVED THAT THE TERMINALS WERE FULLY SEATED INITIALLY DUE TO VISIBLE DRAG MARKS CREATED BY THE METAL TERMINAL SCRAPING THE PLASTIC CASING WHEN EXCESSIVE FORCE WAS APPLIED. THESE MARKINGS ARE PRESENT FROM THE POINT OF TERMINAL SEATING DOWN TO WHERE THE TERMINALS LIE CURRENTLY. PTS IS CONFIDENT THAT THIS DAMAGE OCCURRED POST-DISTRIBUTION, AS THERE ARE NO MANUFACTURING STEPS THAT WOULD CAUSE THIS TYPE OF DAMAGE.

Description of Event or Problem

THERE WERE NO ALLEGATIONS OF PATIENT HARM OR INCORRECT RESULTS. THE CUSTOMER REPORTED THAT THEIR CARDIOCHEK PLUS ANALYZER "KEEPS GETTING WARM TO TOUCH". THE REPORTED ANALYZER WAS BEING USED BEYOND IT'S RECOMMENDED DEVICE LIFE AT THE TIME THE INCIDENT OCCURRED.