Description of Event or Problem · 1
(B)(6) 2018, PRESCRIPTION (B)(4) OBTAINED FREESTYLE LITE GLUCOMETER (PRODUCT FROM LANCETS PRODUCT OF USA (B)(4) REV A 08/10 FROM (B)(4), (B)(4); (USED SAMPLE STRIPS INITIALLY FOLLOWED BY REFILLED STRIPS, BEGAN MONITORING 3 X DAILY THROUGH TO (B)(6) 2018. INFORMED (B)(4) AND ABBOTT ((B)(4)). ABBOTT PROMISED TO SEND NEW METER WITH STRIPS, DID NOT RECEIVE OVER 1 WK; INFORM (B)(4) OF EGREGIOUS ERROR - NOT REMOVED FROM SHELVES. I HAVE DOCUMENTED ALL READINGS/LOT NUMBER. (B)(4) ON (B)(4) 2018 - SAID "EXP DATES ARE OK" AND HAVE NOT RECEIVED CALL FROM EITHER ABBOTT PHARM REP OR (B)(4) DEPT (REFUSES TO F/U AND TAKE OFF SHELF). I WAS TOLD BY ABBOTT THAT THE STRIPS ARE "OLD." THE FOLLOWING ARE THE LOT #S 1030956, EXP 08/31/2019, (B)(4); I CAN GIVE YOU THE (01) NUMBERS FOR THE FOLLOWING: 1026467; 1030958; 1030956, EXP 09/30/2019; 1026467, EXP 08/31/2019 (I HAVE THE CONTAINERS EXCEPT ONE THAT I THREW AWAY. I HAVE DOCUMENTED ALL READINGS THROUGH (B)(6) 2012. HERE ARE A FEW EXAMPLES OF THE ERRONEOUS READINGS: EVERY AM FASTING 111 UNTIL (B)(6); ON (B)(6) LOT 1030956 AM READING = PM READING OF 128; LEFT MESSAGE TO ABBOTT CUST. CARE (AFTER BEING TOLD THERE WAS NO RECORD OF MY PHONE CONVERSATION; TOLD I WOULD BE CONTACTED THE NEXT DAY - NO PHONE CALL. IN SHORT (B)(4) AND ABBOTT ARE NOT COOPERATING. SAW MY MD ON (B)(6) 2018 - INFORCED THAT I NEED TO RESOLVE THIS ISSUE. AT THIS POINT I DO NOT KNOW WHAT TO DO. I AM REACHING OUT TO THE FDA FOR 2 REASONS (OTHER CONSUMERS HAVE RECEIVED GLUCOSE MONITOR STRIPS FROM (B)(4) LOCALLY AND PROBABLY BEYOND THAT ARE NOT CORRECT, AND I NEED TO CONTINUE TO MONITOR MY OWN READINGS. PLEASE CALL ME (B)(6) AND ADVISE ASAP. THIS IS AFFECTING MY HEALTH CARDIOVASCULAR, HEADACHES, ETC. I CAN SEND COPIES OF MY READINGS, BUT TRUST ME THEY ARE SIMPLY NOT ACCURATE. I HAVE CLEARED THE EQUIPMENT AS PER INSTRUCTIONS, FOLLOWED ALL DIRECTIONS APPROPRIATELY.