FDA Warning to GenStrip Maker
FDA issues a waring to the maker of GenStrips. Details at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm402685.htm
Posts Categorized / Blog
Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error
From : http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm400668.htm [Posted 06/11/2014] AUDIENCE: Consumer, Family Physician, Pharmacy ISSUE: Diabetic Supply of Suncoast, Inc. initiated a nationwide voluntary recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the Redi-Code+ BMB-BA006A blood glucose
Surveillance Success!
Good News! The Diabetes Technology Society (DTS) has announced the launch of the DTS Surveillance Program for Cleared Blood Glucose Monitors. This surveillance program will provide independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance against accepted standards, and generate information that can assist patients, healthcare providers,
The Diabetes UnConference, an Uncommonly Good Idea
The Diabetes Collective, Inc. just announced The Diabetes UnConference, the first peer-to-peer support conference for all adults with diabetes. The Diabetes UnConference will be held at the Flamingo Las Vegas from March 12 – 15, 2015. What a great idea. The best part of any diabetes event is connections. This event takes that idea and brings it to
556, Thanks – Congratulations DOC!
StripSafely salutes the Diabetes Community’s strong and sustained level of comments to the FDA Glucose meter dockets. Accuracy Matters. Thanks! Here is the count at close: The personal use ‘over the counter’ docket 373* The professional ‘prescription’ use docket 183* 556 Comments! Ain’t America Great? * FDA notes: This count refers to the total comments received
MasterLab – July 2. Become a better advocate
Become a stronger champion for effective diabetes policy. July 2, 2014 7am – 5pmOrlando World Center Marriott Speakers include: Patient advocates from other diseases FDA Government and Regulatory Affairs representatives from device and pharmaceutical companies Other experts. Understand the role of patients, empower diabetes advocates: Policy, regulatory issues What advocacy looks like now and where we can
Meter and Hospitals – DTS Meeting
With Dr Klonoff’s blessings we are happy to share information about this Diabetes Technology Society meeting: Dr. David Klonoff invites you to attend the Hospital Diabetes Meeting May 13, 2014 Hyatt Arlington, Arlington, Virginia (www.diabetestechnology.org/hospital/) Point of Care Blood Glucose Monitors (POC BGMs) are currently being used for purposes other than those cleared by the
FDA: Safety Warning – GenStrip Generic Strips
StripSafely asked Who is Accountable for generic test strips. Apparently it is not a academic question. FDA today release a warning titled, “FDA Safety Communication: Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results“ FDA is advising these Strips not be used. FDA ask retailers to stop selling and remove them from distribution shelves. FDA
FDA / DOC Chat Online!
FDA hosted a conversation with the diabetes community on meter accuracy. FDA’s Dr. Courtney Lias was interviewed by StripSafely’s Bennet Dunlap. It is online now! At FDA’s Patient Network. Note to iOS users, the FDA site uses Flash. Watch and Comment to FDA. Please share on social media with the hashtag #DOCasksFDA.
Third Party Strips – Who is Accountable?
FDA considers a glucose meter and strips a complete system. When a third party manufacturer makes test strips for a meter, who do you think should be responsible for a problem: the meter company, the strip company or the patient for not seeing the fine print and matching the meter with the correct production date