Insulet Issues a Medical Device Correction Notice for Insulin Pump System
Medical device maker Insulet (NASDAQ: PODD) issued a voluntary medical device correction notice for its Omnipod DASH Insulin Management System Thursday, warning that there is a remote possibility that the devices may deliver an incorrect amount of insulin, which could lead to hypoglycemia or hyperglycemia. The company will replace the devices when a software update becomes available in March.
Insulet's Omnipod system includes a wearable pod that delivers insulin doses and a controller that looks like a smartphone, called the Omnipod DASH Personal Diabetes Manager (PDM). The software problem affects the bolus calculator feature of the PDM, which patients use to compute the amount of insulin they will need in their next dose. Under certain rare circumstances, the device could recommend a bolus based on an older blood glucose reading.
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Source Fool.com
