001), and they spent 43 minutes less time in hypoglycemia per day. In the trial, among 156 participants with type 1 diabetes and mean baseline A1c around 8.6%, those randomized to the intermittently scanned FreeStyle Libre 2 (Abbott Diabetes Care) experienced a 0.5 percentage point greater drop in A1c at 24 weeks compared with usual fingerstick blood glucose testing ( P <. Just today, a new study has been published in the New England Journal of Medicine detailing results of the FLASH UK study.
There's plenty of literature at this point on the advantages of CGM in type 1 diabetes.
#FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM CLASS II B CODE#
This record will be updated as the status changes.ĥ10(K)s with Product Code = QLG and Original Applicant = Abbott Diabetes Care Inc.He began by listing the advantages of CGM, including improved glycemic control, safety in the form of alarms for low glucose levels, avoidance of the inconvenience of fingerstick glucose monitoring, and the capacity of CGM to enable closed-loop insulin delivery, also known as artificial pancreas systems. Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ The manufacturer has initiated the recall and not all products have been corrected or removed. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. US Nationwide distribution in the states of FL, GA, SC.ġ A record in this database is created when a firm initiates a correction or removal action. RETURN the enclosed acknowledgment form via fax to 1-81 or email to even if you do not have any product on hand.Ĥ.ĜONTACT Inmar to arrange for return and credit of any affected product: 1-85 (9:00 AM to 5:00 PM, Monday thru Friday) SEGREGATE and QUARANTINE all affected product.ģ. INSPECT your inventory for the affected product.Ģ. On, Cardinal Health issued an Urgent Medical Device Removal notice to customer via letter notifying them a recall is being initiated as a precautionary measure as a result of exposure to temperatures outside of the products labeling requirements.ġ. NDC/UPC: 57599080000 All lots numbers shipped from 2/23/201 to ĭue to shipping delays the devices were exposed to temperature excursions of 31.9❿, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delive - Product Code QLGįREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 Class 2 Device Recall FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM
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