If the Reader is damaged or a replacement USB cable or power adapter (charger) are needed, call Abbott's Customer Service at 1-85 to request a replacement.
You do not have the Abbott provided USB cable and power adapter (charger). If the Reader is no longer able to hold a charge (for example, if it turns off unexpectedly or immediately after charging). 
If there is visible swelling of the Reader. Stop using the FreeStyle Libre Reader and switch to a back-up method ONLY if you experience any of the following: If you have the Abbott provided USB cable and power adapter AND you are not experiencing the problems listed below, you can continue to use the Abbott provided Reader, USB cable, and power adapter. On February 13, 2023, Abbott sent some users of the FreeStyle Libre family of Readers an Urgent Medical Device Correction letter. Health care providers with patients who use FreeStyle Libre, Libre 14 day, or Libre 2 systems to monitor their glucose levels. People who monitor their glucose levels using the FreeStyle Libre, Libre 14 day, or Libre 2 Glucose Monitoring Systems. There have been 88 incidents, including at least seven reports of fires, one injury, and no deaths involving this issue. Additionally, users may delay or miss a critical diabetes treatment if the system cannot be used after is damaged by extreme heat or fire. The Reader, if not properly stored, charged, or used with its Abbott provided USB cable and power adapter, may expose users to extreme heat and/or fire which can cause serious injuries or death. The Abbott-provided USB cable and power adapter limit the power provided to safely charge the battery, whereas USB cables and power adapters manufactured by a third party may allow much higher power, increasing the risk of overheating, spark, or fire. Examples of misuse include exposure to liquids, damage, and introduction of foreign material into the ports. The potential for overheating, spark, or fire may occur when charging the Reader with non- Abbott adapters or non-Abbott USB cables combined with misuse of the Reader and its components. This does not affect any of the FreeStyle Libre family of sensors. Reason for RecallĪbbott is recalling the FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Management Systems’ reader devices, which use rechargeable lithium-ion batteries, may get extremely hot, spark, or catch on fire if not properly stored, charged, or used with its Abbott provided USB cable and power adapter. They are indicated for single patient use, and require a prescription. These devices help people manage diabetes by detecting trends and tracking patterns in glucose levels so treatment can be adjusted as needed. The FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Monitoring Systems are intended to provide continuous monitoring of glucose levels. Date Initiated by Firm: February 13, 2023. 
Devices Recalled in the U.S.: 4,210,785.Distribution Dates: Beginning November 2017.
Freestyle libre flash glucose monitoring serial numbers#
Product Models: all Reader serial numbers. Product Name: FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System. Use of these devices may cause serious injuries or death. 
The FDA has identified this as a Class I recall, the most serious type of recall. In this case, the firm is correcting the product labeling and not physically removing all the readers as part of this recall.Īdditional information, including recommendations, and what to do if a reader needs to be returned can be found in the What to Do section. If you are not experiencing problems with the Abbott provided Reader and you have the Abbott provided USB cable and power adapter, you can continue to use the Abbott provided Reader, USB cable, and power adapter.Ī medical device recall means a firm’s removal or correction of a medical device.
On April 12, 2023, the FDA added information for patients about Abbott’s April 2023 Medical Device Correction letter.
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