Description of Event or Problem · 1
IN 2010, ABBOTT DIABETES CARE SWITCHED TO A NEW FORMULATION FOR THEIR FREESTYLE TEST STRIPS. THE NEW FORMULATION IS FDA APPROVED FOR FREESTYLE 3, FREESTYLE 5, FREESTYLE FREEDOM AND FREESTYLE FLASH METERS. MY WIFE, HOWEVER, USES INSULET'S OMNIPOD INSULIN PUMP WITH THE OLD FORMULATION OF THE FREESTYLE TEST STRIPS. THE FDA HAS NOT APPROVED THE USE OF THE NEW STRIPS WITH THE METER EMBEDDED IN THE OMNIPOD CONTROLLER, AND ANECDOTAL EVIDENCE ON THE INTERNET IS THAT TESTING WITH THE NEW STRIPS IN THE OMNIPOD YIELDS SIGNIFICANTLY INCORRECT BLOOD GLUCOSE READINGS. THE PROBLEM WE ENCOUNTERED AS CONSUMERS IS THAT WHILE THE NEW FORMULATION IS NOT FDA APPROVED FOR ALL DEVICES THE OLD FORMULATION WAS APPROVED FOR, ABBOTT RELEASED THE NEW STRIPS USING THE SAME NATIONAL DRUG CODE (NDC) AS THE OLD STRIPS. THIS LED TO OUR PHARMACY INADVERTENTLY FILLING A REFILL ORDER WITH THE NEW STRIPS WITHOUT WARNING. LUCKILY, THE PRODUCT DIFFERENCES WERE NOTICED BEFORE USE, AND ABBOTT WAS WILLING TO SWAP THE TEST STRIPS OUT FOR THE CORRECT ONES. WHEN AN ITEM CANNOT BE USED EQUIVALENTLY FOR ALL APPROVED USES, I WOULD SUGGEST THAT THE MANUFACTURER BE REQUIRED TO USE A DIFFERENT IDENTIFIER (THE NDC IN THIS CASE) TO MINIMIZE THE CHANCE FOR MISTAKES DUE TO ITEMS APPEARING TO BE THE SAME TO COMPUTER SYSTEMS. MOREOVER, I WISH TO NOTE THAT AS CONSUMERS THIS SORT OF CONFUSION CAN BE DIFFICULT TO RESOLVE, ESPECIALLY WHEN DEALING WITH HIGHLY-AUTOMATED MAIL-ORDER PHARMACIES, SINCE TO THEM THE PRODUCT VARIATIONS ARE THE EXACT SAME ITEM.