Description of Event or Problem · 0
I AM USING FREESTYLE LIBRE 2 (K193371). WHILE IT SUPPOSED TO HAVE ABOUT 20% ACCURACY FOR GLUCOSE MONITORING, I ENCOUNTERED A VERY DANGEROUS SITUATION WHEN RELYING ON IT'S READING SUGAR LEVEL. THERE WERE 2 MAIN CASES: 1. IN ONE OCCASION, MY FATHER WAS 10 HOURS FASTING BEFORE A BLOOD TEST IN THE EARLY MORNING. I CHECKED HIS SUGAR LEVEL WITH THE ABBOT MONITOR AND IT SHOWED 195 MG/DL AT 8:11, WHEN CHECKING WITH MY DAD WHY HE EAT, HE TOLD ME THAT BESIDE DRINKING WATER HE DIDN'T EAT ANYTHING. I CHECKED AGAIN AT 8:13 AND STILL THE SAME NUMBER 195 MG/DL. THEN I CHECKED WITH HIS ACCUE-CHECK GLUCOSE METER AND IN 2 DIFFERENT TESTS IN SEPARATE FINGERS IT SHOWED 100 MG/DL AND 98 MG/DL. LATER I CHECKED AGAIN IN THE ABBOT MONITOR AND IT SHOWED 184 MG/DL. I HAVE GOT NO INDICATION OR ALARM OF A WRONG OR UNRELIABLE TEST, JUST A NUMBER THAT WAS VERY "MISTAKABLY" WRONG AND DANGER, BECAUSE I WAS ABOUT TO GIVE HIM AMARYL MEDICATION IN ORDER TO REDUCE THE VERY HIGH GLUCOSE LEVEL I HAVE GOT FROM THE ABBOT MONITOR. I WANT TO MENTION THAT: A. THE ABBOT EQUIPMENT WAS ON THE APPROPRIATE PLACE AND CONDITION AND NOT LOCATED ON THE MUSCLE PLACE. B. MY FATHER ALMOST NOT MOVING AS A RESULT OF A BROKEN LEG (LYING MOST OF THE TIME); C. NO PRESSOR ON THE SENSOR AT ALL; D. HE WAS NOT EATING AT ALL, SO NO VITAMIN C OR OTHER STUFF SHOULD INFLUENCE. E. THE BLOOD TEST WAS LAB VALIDATED IN THE SAME MORNING AT 08:30 AND IT WAS "98.3 MG/DL F." THE ABBOT GLUCOSE MONITOR WAS APPROXIMATELY CORRELATED WITH THE EATING TIME OF MY FATHER MOST OF THE TIME IN THE 1 WEEK BEFORE AND JUST 5 DAYS FROM THE END OF 14 DAYS IT SHOWED MORE AND MORE ALARMS TO WAIT 10 MIN FOR GETTING THE READINGS 2. WHEN REPLACING THE ABBOT SENSOR WITH A FRESH NEW ONE, THE PROBLEM OCCURRED AGAIN , BUT IN THE OTHER WAY. NOW THE SENSOR READING WAS 73 MG/DL INSTEAD OF 194 MG/DL I RECEIVED IN THE ACCUE-CHECK (ALMOST 300% MISTAKE) THE TWO SENSORS, THE PICTURES AND VIDEOS I TOOK AND BLOOD TEST RESULT ARE IN MY POSITION NOW. SHOULD I SEND THEM BACK TO THE COMPANY OR LET THEM STAY WITH ME FOR YOUR INVESTIGATION? FDA SAFETY REPORT ID # (B)(4).