Device turns off immediately after being removed from the charger or fails to turn on within 45 minutes of being connected to the charger.Extreme overheating (that may pose a fire hazard) or an odor while charging, during use, or in storage.The PDM’s gel skin will need to be removed to observe these issues, but do not remove the back cover. Do not apply pressure to the back cover if it is deformed in any way. Monitor the DASH Insulin Management System PDM for any of the following issues:.The letter recommended the following actions for the Omnipod DASH Insulin Management System PDM: On October 17, 2022, Insulet sent users an Urgent Medical Device Correction email and letter. Health care providers with patients who manage their insulin levels using the Omnipod DASH Insulin Management System PDM.People who manage insulin levels using the Omnipod DASH Insulin Management System PDM.There have been no reports of injuries or deaths. Insulet reports 455 complaints involving these battery issues, including three fires. Users could be exposed to battery fluid and extreme heat, including the potential for an explosion and/or fire, which could lead to serious injury or death. Extreme overheating that may pose a fire hazard.Insulet is recalling the Omnipod DASH Insulin Management System’s Personal Diabetes Manager (PDM) after receiving reports of PDM battery issues, including: The Pod is controlled exclusively using the PDM and the two parts interact wirelessly using secure Bluetooth. The PDM is a small, reusable handheld rechargeable battery-powered locked-down Android mobile device with features similar to a smartphone. It includes two main parts: The wearable and tubeless pump which delivers the insulin, called the Pod, and a remote controller called the Personal Diabetes Manager (PDM). The Omnipod DASH Insulin Management System is used to deliver insulin at set and variable rates to manage diabetes in people who need insulin. Date Initiated by Firm: October 17, 2022.Distribution Dates: Jto August 31, 2022.PT-000011: Assembly, DASH Final PDM U100, mmol/L.PT-000010: Assembly, DASH Final PDM U100, mg/dL.Product Name: Insulet Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM).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.
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