Description of Event or Problem · 1
ON (B)(6) 2016 FDA LETTERS (B)(6). HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/MEDWATCH/INDEX.CFM?ACTION=CONSUMER.REPORTING1. I AM A MEDICAL RESEARCH WITH TRAINING IN HEMATOLOGY AND IMMUNOLOGY, ((B)(6)) I AM ALSO A DIABETIC. I WOULD LIKE TO REPORT ONE TOUCH VERIO DEVICE GIVING (MORE THAN TEN) FALSE POSITIVES REPORTED AS CONTROL FOR BLOOD SAMPLES AND HIGH READINGS VS MY OLD READER. IN THE PAST 10 DAYS, (B)(6) UNTIL TODAY, I TALKED TO LIFESCAN RE THE PROBLEM. THEY WANT TO REPLACE AND BARRIER THE HEALTH CARE PROBLEM. I ALSO TEST WITH ABBOTS FREE STYLE FREEDOM LITE, THAT I HAVE BEEN USING OVER THE PAST SEVERAL YEARS. DUE TO INSURANCE SWITCHING, I WAS GIVEN A NEW SYSTEM, THE VALUES ARE HIGHER FOR ONE TOUCH VS THE FREE STYLE DEVICE. I WILL RUN A STUDY AND REPORT MY FINDINGS USING THE ABBOTT SYSTEM AS MY CONTROL DEVICE AND TESTING BOTH READERS WHEN I RECEIVE THE NEW DEVICE. I AM A SR. CLINICAL RESEARCH DIRECTOR AND DEVELOPMENT SCIENTIST WITH OVER 25 YEARS EXPERIENCE PROPOSING, DEVELOPING AND EXECUTING PROJECTS. EXPERTISE IN IMMUNOLOGY AND MOLECULAR PRODUCTS AND TECHNOLOGY. FACILITATED THE TRANSFER OF KNOWLEDGE FROM THOUGH LEADERS TO OTHER SCIENTIST, ADVOCACY GROUPS, SALES, AND SUPPORT AND MARKETING TEAMS. SERVE AS A SCIENTIFIC AND CLINICAL SUPPORT RESOURCE FOR SEVERAL COMPANIES. THIS INCLUDED DIRECT SCIENTIFIC AND MEDICAL SUPPORT DURING INTERACTIONS WITH SCIENTIST, ADMINISTRATORS OR PAYERS. PROVIDE PEER-LEVEL LEADERSHIP, MENTORING AND TRAINING FUNCTIONS FOR RESEARCH AND DEVELOPMENT, SUPPORT AND SALES TEAMS. DEVELOPED PROCESS AND PERFORM TECHNOLOGY TRANSFER AND PRODUCT LAUNCH FOR FDA AND IVD APPROVED PRODUCTS. WRITE DOCUMENTATION FOR PERFORMANCE VS. DESIGN TEST. TEST SYSTEM INSTRUMENTS REAGENTS AND SOFTWARE. MANAGED CLINICAL RESEARCH FOR FILING 510, IND AND PRE-MARKETING APPROVALS, PERFORM MARKET DEVELOPMENT ACTIVITIES FOR NEW PRODUCTS AND INDICATIONS. PROVIDE ASSISTANCE ON SPECIAL PROJECTS IN CONJUNCTION WITH PROJECT MANAGEMENT, R AND D, MARKETING, SALES, CLINICAL DEVELOPMENT, RESEARCH AND DEVELOPMENT AND QUALITY ASSURANCE. BLOOD GLUCOSE METER SSN XBHMN1H8 ONE TOUCH VERIO FALSE POSITIVE SHOWING AS CONTROL WHEN SAMPLE LOT WAS BLOOD FROM FINGER STICK. I KNOW HOW TO FOLLOW IVDP INSTRUCTIONS. C IS FOR CONTROL SOLUTION NOT BLOOD. ALL READINGS ARE MG/ML OF GLUCOSE FROM MY BLOOD. I HAVE READING FROM MY OLD METER FREEDOMNSTYLE FREEDOM LITE FROM ABBOTT THAT HAS A 15 30% LESS READINGS OF GLUCOSE MG/ML. I LOVE THE GLUCOSE METER AND INSURANCE CHANGE VENDORS (B)(6)- 7:14 AM C89 BLOOD, (B)(6)- 7:17 C121 BLOOD, (B)(6)- C168 BLOOD, (B)(6)- 7:32PM, C109 BLOOD (B)(6)-7:32PM C112, (B)(6) -7 :54AM C 146 BLOOD, (B)(6) 6:04 PM C186 BLOOD, (B)(6) 6:05PM C124 BLOOD, (B)(6) 5:08AM C125, 5:10 AM C150MG/ML, 5:11 AM C121, 5:12AM C136, 5:14AM C132 8:13AM C257 9:53AM C131 9:56AM BLOOD READING AT 228 MG/ML 3 MINUTES ARE YOU CRAZY FEB 05 12:55 PM I GOT A SUGAR READING OF 103 FROM BLOOD AFTER INJECTION OF INSULIN (HUMALOG FROM LILLY).