Description of Event or Problem · 1
I PURCHASED AN ACCUCHEK GUIDE AND METER BECAUSE IT IS FORCED ON ME TO PURCHASE THAT METER BY MY HEALTHCARE COMPANY AND EMPLOYER. I PURCHASED THE METER AND TEST STRIPS ON THURSDAY (B)(6) 2019 FROM A (B)(6) PHARMACY IN (B)(6), AND BECAUSE OF MASSIVE TEST STRIP FAILURES, I HAVE USED OVER 29 OF 50 TEST STRIPS IN ONE TEST STRIP CONTAINER ALREADY IN JUST 3 DAYS' TIME. EITHER THE TEST STRIPS, DEVICE OR BOTH ARE COMPLETELY UNRELIABLE AND DEFECTIVE, WHICH PUTS DIABETICS LIKE ME IN A LIFE-THREATENING SITUATION. I CANNOT USE A BRAND NEW ACCUCHEK DEVICE OR ITS TEST STRIPS FOR BLOOD GLUCOSE TESTING WHEN THE MAJORITY OF THE TEST STRIPS PRESENT AN ERROR, NOR DO I BELIEVE THAT TEST RESULTS ARE RELIABLE. I AM ALSO SEEING A FEEDBACK ON VARIOUS FORUMS FROM OTHER CUSTOMERS AND USERS OF THIS DEVICE, THAT MASSIVE TEST STRIP FAILURE RATES ARE A COMMON WITH THIS DEVICE. I BELIEVE THAT ACCUCHEK IS ENGAGING IN LIFE-RISKING MFG OF UNSTABLE AND UNUSABLE TEST STRIPS. THE ERROR CODE SEEN ON MY DEVICE AND WITH THE BRAND-NEW TEST STRIPS I PURCHASED IS E-3. I AM FINDING I GET AN ACTUAL TEST RESULT (VERSUS E-3) IN AN AVERAGE OF 1 IN EVERY 5 STRIPS. I'VE BEEN USING A TEST METER FOR YEARS (BAYER ULTRA ONE TOUCH), AND NEVER HAD A PROBLEM WITH FAILURES (MAYBE ONE IN 1,000 TEST STRIPS OR LESS). THAT MEANS FOR A PACK OF 50 OF THE ACCUCHEK TEST STRIPS I ONLY HAVE AROUND 80 USABLE STRIPS. I WAS PRESCRIBED 400 TO TEST 4-5 TIMES A DAY WHICH SHOULD LAST ME 90-100 DAYS, BUT I WILL BE OUT OF THAT AMOUNT AND IN AROUND 20 DAYS. THE LOT NUMBER OF THE TEST STRIPS IS 101317, USE BY 01/04/2021, SN (B)(4). DEVICE DETAILS: ACCUCHEK GUIDEMEBLOOD GLUCOSE MONITOR. CAT # 0849986001, NDC 65702-0731-10, SN (B)(4), GTIN (B)(4), MODEL 897. ACCUCHEK IS PUTTING PEOPLE'S LIVES AT RISK BY MFG ALMOST ENTIRELY DEFECTIVE AND WHOLLY UNRELIABLE TEST STRIPS AND/OR DEVICES THAT DIABETICS CANNOT USE OR RELY ON WITH ANY CONSISTENCY. I HAVE NOT SEEN A RECALL FOR THIS DEVICE OR TEST STRIPS, BUT HAVE SEEN RECALLS FOR OTHER ACCUCHEK DEVICES / TEST STRIPS. PLEASE HELP, THIS IS A TRAVESTY. THE MEASUREMENTS ABOVE DID NOT REALLY APPLY. ON (B)(6) IT TOOK ON ONE OCCASION 5 TEST STRIPS, AND THE OTHER 6 TEST STRIPS BEFORE A VALID TEST RESULT WAS PRESENTED. ON (B)(6) IT WAS 1 IN 4, 1 IN 2, 1 IN 5 TEST STRIPS. ON (B)(6) IT WAS 1 IN 2, 1 IN 3, ON (B)(6)SO FAR IT'S 1 IN 2, 1 IN 3. I'M NOT USING ANY FORCE TO PLACE THE STRIPS, AND HAVE BEEN USING OTHER TEST METERS FOR YEARS, WITH AN AVERAGE FAILURE ON THOSE AROUND 1 IN 1,000 TEST STRIPS. ALSO I HAD A FEW TEST STRIPS LEFT FROM MY OLD RELIABLE BAYER CONTOUR ULTRA (WHICH IS NOT COVERED BY MY INSURANCE NOR ARE STRIPS). THE TESTING RESULTS AT THE SAME TIME BETWEEN THE TWO DEVICES ARE AROUND 30U DIFFERENCE BETWEEN THE TWO. I DO NOT BELIEVE THE ACCUCHEK IS ACCURATE. THIS IS A PURE TRAVESTY AND ACCUCHEK SHOULD NOT BE ALLOWED TO MANUFACTURE SUCH SHODDY AND UNRELIABLE PRODUCTS THAT PUT PEOPLE'S LIVES AT RISK. FDA SAFETY REPORT ID# (B)(4).