- #Abbott labs freestyle libre flash glucose monitoring system full#
- #Abbott labs freestyle libre flash glucose monitoring system pro#
- #Abbott labs freestyle libre flash glucose monitoring system professional#
Get the full story at our sister site, Drug Delivery Business News. The notice does not affect any of the FreeStyle Libre family of sensors.
All affected products are glucose monitoring systems. It spans the FreeStyle Libre Flash, FreeStyle Libre 14-day and the FreeStyle Libre 2 Flash. Today’s FDA notice offers more detail into which devices the warning affects and how far-reaching it is. FreeStyle Libre is a revolutionary device by Abbott that helps monitor your glucose levels and is designed to liberate people from many of the hassles of glucose monitoring, such as painful finger pricking.
No readers are being physically recalled. Customers can continue to safely use their readers with the Abbott-provided USB cable and power adapter. Customers do not need to return their readers. In very rare cases, users reported that the battery sparked or caught fire. The company said it received a limited number of global reports (0.0017%) from users over several years saying their reader’s lithium-ion battery swelled or infrequently overheated. The FDA today issued a notice classifying a recall of Abbott (NYSE:ABT) FreeStyle Libre readers as Class I, the most serious kind.Įarlier this week, Abbott initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers. Thus, patients can wear it for 10–14 days with minimal disturbance of their activities of daily living.The FreeStyle Libre reader. The sensor is small and discreet, measuring approximately the size of a quarter. Appropriate therapeutic changes can then be made over the phone or through the electronic medical record/patient portal. Fourteen days after placement at a provider’s office, patients can remove the sensor and send it back to the health care provider.
#Abbott labs freestyle libre flash glucose monitoring system pro#
The Freestyle Libre Pro can be an effective tool to coordinate care in virtually any health care setting. Freestyle Libre allows valuable glucose data to be collected even if patients are inconsistent with their blood glucose monitoring. The sensor does not need to be calibrated with blood glucose meter readings to maintain accuracy.
Dexcom and Medtronic CGM systems give falsely high glucose readings when a patient takes acetaminophen ( 2). The Freestyle Libre is also the only CGM system on the market with no acetaminophen interference. The time from a patient’s decision to wear a CGM device to the first delivery can often take months with other CGM systems. Unlike other CGMs on the market, Libre will not need authorizations through specialty distributers. 7 Abbott has secured partial or full reimbursement for the FreeStyle. and worldwide, 8 Abbott's FreeStyle Libre portfolio has changed the lives of more than 2 million people across more than 50 countries 5 by providing breakthrough technology that is accessible and affordable. The Freestyle Libre is available to patients through retail pharmacies. As the 1 sensor-based glucose monitoring system used in the U.S. The downloading and reporting software, LibreView, is also free to the clinic.
#Abbott labs freestyle libre flash glucose monitoring system professional#
The handheld device for reading the sensor stays with the health care professional and is used for all patients. There are no reusable parts that must be sanitized between patients. Only disposable portions of the system are sent home with patients. For the Pro version, the initial cost to the clinic is minimal. The Freestyle Libre has several potential advantages.
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