Description of Event or Problem · 1
AN E-MAIL WAS ORIGINALLY RECEIVED (B)(6) 2008 FROM THE (B)(6) DISTRIBUTOR ((B)(4) OF THE CARDIOCHEK PA SYSTEM. THE REPRESENTATIVE REPORTED THAT THEY HAD RECEIVED A CALL FROM A CUSTOMER STATING THAT HE HAD PURCHASED A CARDIOCHEK PA AND UPON TESTING FOUND HIS CHOLESTEROL RESULTS TO BE LOW AND THUS HE SELF-MANAGED HIS "PILLS FOR LOWERING CHOLESTEROL." THE DRUG WAS IDENTIFIED AS VAZILIP, WHICH CONTAINS THE ACTIVE AGENT SIMVASTIN, A STATIN. THE NEXT DAY, THE PATIENT WENT TO THE HOSPITAL AND WAS TOLD BY THE HOSPITAL PHYSICIAN THAT THE CARDIOCHEK RESULTS WERE WRONG. ADDITIONALLY THE DISTRIBUTOR REPORTED THAT THE CARDIOCHEK INSTRUMENT WAS WORKING CORRECTLY SO THERE MUST BE SOMETHING WRONG WITH THE LIPID PANEL TESTS. UPON FURTHER INQUIRY FROM PTS, THE DISTRIBUTOR SENT A LIMITED AMOUNT OF DATA ON (B)(6) 2008 WITHOUT PROPER IDENTIFICATION OF THE DATA SOURCE. FURTHER ATTEMPTS TO GET EXPLANATION FROM THE DISTRIBUTOR WERE UNSUCCESSFUL. SPECIFICALLY PTS SOUGHT TO UNDERSTAND WHY THE PATIENT, IF PRESENTED WITH LOW CHOLESTEROL NUMBERS, WOULD ELECT TO TAKE MORE DRUG TO IMPROVE THEIR ASSUMED CONDITION. THE TAKING OF THIS EXTRA MEDICATION WOULD ONLY SERVE TO LOWER THE CHOLESTEROL FURTHER. INDEED THE TIMELINE OF THE TEST RESULTS SEEMS TO INDICATE A SERIES OF HIGH CHOLESTEROL VALUES, FOLLOWED BY A LINE DEMARCATING SOME ACTION OR ACTIVITY AND THEN LOWER CHOLESTEROL VALUES. WHILE IT IS NOT CLEAR THAT THE CARDIOCHEK OR THE LIPID PANEL TESTS HAD EITHER FAILED OR LED TO AN IMPROPER MEDICATION CHANGE, WE ARE SUBMITTING THIS MEDICAL DEVICE REPORT SINCE THE CUSTOMER HAD VERBALIZED TO THE DISTRIBUTOR'S AGENT THAT "HE ALMOST DIED BECAUSE OF THE CARDIOCHEK." WE WILL CONTINUE TO MONITOR THIS SITUATION WITH THE DISTRIBUTOR AND SEEK TO UNDERSTAND THE DETAILS OF THE REPORTED INCIDENT. AT THIS TIME, THERE IS NO CONFIRMATION THAT THE CARDIOCHEK CONTRIBUTED TO THIS PATIENT'S CONDITION WHICH LED TO THE VISIT TO THE HOSPITAL. WE WILL AMEND THIS REPORT WHEN WE RECEIVE MORE SPECIFIC AND ACCURATE INFORMATION.