Description of Event or Problem · 1
MY CONCLUSION: ONE TOUCH VERIO GLUCOMETER "SIGNIFICANTLY" OVER ESTIMATES BLOOD GLUCOSE (BG)LEVELS IN THE GREATER THAN 138 MG RANGE. THIS HAS THERAPEUTIC CONSEQUENCES AND THUS A SAFETY HAZARD FOR ALL DIABETIC PATIENTS WHO USE THIS GLUCOMETER. BACKGROUND TO MY CONCLUSION: I ENROLLED WITH (B)(6) PLAN STARTING (B)(6) 2016 AND WAS TOLD THAT THEY ONLY SUPPLIED THE ONE TOUCH VERIO IQ GLUCOMETER AND TEST STRIPS UNDER THE PLAN (NOT ACCUCHEK AVIVA STRIPS THAT I HAD BEEN USING FOR 15 PLUS YEARS). I ACCEPTED THAT AND SINCE I HAD ACCUCHEK STRIPS LEFT WITH ME, I TESTED THE ONE TOUCH VERIO METER AGAINST THE ACCUCHEK AVIVA. THE RESULTS ARE POSTED IN THE LAB DATA SECTION BUT CONCLUSIONS ARE DRAWN HERE FROM THAT RAW DATA BLOOD GLUCOSE READINGS WITH ONETOUCH VERIOIQ (OT) METER AND ACCUCHEK AVIVA (AA) METER AND CONCLUSIONS 30 TIME POINTS: 11 FASTING; 9 - 2 HOUR PP LUNCH: 10 - 2 HOUR PP DINNER. TOTAL 44 MEASUREMENTS (SINGLE/MULTIPLE FROM THE SAME FINGER STICK) - 15 - 30 SECONDS APART. BOTH METERS WERE TESTED WNL WITH THEIR RESPECTIVE CONTROL SOLUTIONS: AA LEVEL 1 (30-60). LEVEL 2 (254 - 344) OT-102-138. OT DOES NOT OFFER A CONTROL FOR HIGHER LEVELS. MY TARGET THRESHOLDS ARE AND HAVE BEEN FOR THE LAST 15 YEARS: FASTING: LESS THAN 100. TWO HOUR PP BELOW 160. RELEVANT ANALYSIS FROM RAW READINGS LISTED BELOW (COLOR CODES ARE ON MY SPREADSHEET WHICH I CANNOT ATTACH TO THIS REPORT UNFORTUNATELY). RED - LEVELS WITHIN MY THRESHOLDS BY AA BUT OUTSIDE THRESHOLDS BY OT. THIS HAS TREATMENT AND DIABETES MANAGEMENT IMPLICATIONS. YELLOW - HIGHER READINGS BY OT COMPARED TO AA; THERE WERE 10 REDS AND 9 YELLOWS OUT OF 30 (19/30: 63 PERCENT); 10/30 (33.3 PERCENT) WERE REDS WHICH MEANS THERE ARE THERAPEUTIC IMPLICATIONS OF THIS OVER ESTIMATION OF BG LEVELS; 18/44 (41 PERCENT) READINGS SHOWED HIGHER READINGS BY OT OVER AA. TEN OF 18 WERE MORE THAN 20 (55.5 PERCENT); THE YELLOW AND RED FLAGS WERE MOSTLY IN THE HIGHER SUGAR RANGES (17 OUT OF 19 - 89 PERCENT) FOR WHICH THERE ARE NO CONTROLS PROVIDED TO CHECK THE ACCURACY. MY SUSPICION IS THAT THE "PROJECTED PLASMA EQUIVALENT" VALUES IN THE UPPER RANGE ARE NOT PROPERLY CALIBRATED AGAINST THE MORE ACCURATE LAB METHODOLOGY RESULTING IN AN OVER READ. AFTER I GOT A SECOND HYPOGLYCEMIC ATTACK (FIRST (B)(6), SECOND ON (B)(6) NIGHT), DATA WAS SENT TO (B)(6) ON (B)(6). I STOPPED USING THE OT METER AND MADE AN APPEAL TO PROVIDE ME WITH THE AVIVA STRIPS. THEY PROMPTLY AGREED AND IMMEDIATELY PROVIDED THE AVIVA STRIPS. AS A PHYSICIAN, I WAS CONCERNED ABOUT ALL DIABETIC PATIENTS, SO I SENT THE SAME DATA AND CONCLUSIONS TO LIFESCAN ON 05/24 FOR THEIR REVIEW. SUBSEQUENT TO THAT, TWO CONFERENCE CALLS WERE HELD ON (B)(6) BETWEEN ME AND LIFESCAN MEDICAL OFFICER AND SAFETY OFFICER (DR. (B)(6)). IT IS CLEAR LIFESCAN IS GIVING ME THE USUAL COMPANY RUN AROUND RESPONSE OF REFERENCES, POST APPROVAL STRIP/BATCH ACCURACY RESULTS ETC WITHOUT ANSWERING MY BASIC QUESTION. AS A PATIENT, WHICH GLUCOMETER SHOULD I TRUST TO MANAGE MY DIABETES? AA OR OT? 0. ONE IS UNDER ESTIMATING OR THE OTHER OVER ESTIMATING. MY EXPERIENCE AND CONCLUSION IS THAT OT OVER ESTIMATES BG LEVELS AND HAD AN ADVERSE EFFECT ON ME TRYING TO MODIFY MY DIET TO BRING THE BG LEVELS WITHIN MY THRESHOLDS. MOST SURPRISING WAS WHEN THEY TOLD ME ON THE (B)(6) CONFERENCE CALL THAT AFTER ESCALATING THIS ISSUE INTERNALLY, LIFESCAN SAFETY TEAM CONCLUDED THAT THIS WAS NOT A SAFETY ISSUE. I STRONGLY DISAGREE WITH THAT CONCLUSION. I AM CONCERNED ABOUT ALL DIABETIC PATIENTS (PARTICULARLY TYPE I DIABETICS) WHO USE THIS METER TO ESTIMATE THEIR INSULIN REQUIREMENTS. A FALSE HIGH BG LEVEL READING CAN END UP CAUSING AN OVER ESTIMATION OF INSULIN NEED AND CAN RESULT IN A HYPOGLYCEMIC REACTION.