The device was not returned for evaluation.We are unable to confirm the reported needle mechanism failure or to determine its root cause.Lot release records were reviewed and the product lot met all acceptance criteria.Omnipod insulin management system ¿ user guide.Model: ent450.17845-5c-aw rev a 10/17.Using the pod 3/ page 32-33.Check the infusion site: following insertion of the cannula, check the infusion site: look through the viewing window to check that the cannula is inserted into the skin.The cannula is tinted light blue.Check for pink coloring in the area on the top of the pod shown in the figure.This is an additional check that the cannula was extended.Check for wetness or the scent of insulin at the insertion site.The presence of either may indicate that the cannula has dislodged.Warning: check the infusion site after insertion to ensure that the cannula was properly inserted.If the cannula is not properly inserted, hyperglycemia may result.
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