The device was not returned for evaluation.The patient reported that the cannula had dislodged from the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.Mylife omnipod insulin management system ¿ user guide.Model: ent450.14518-5c-aw rev e 03/16.Using the pod 5 / page 42.Warning: check often to make sure the pod and soft cannula are securely attached and in place.A loose or dislodged cannula may interrupt insulin delivery.Verify there is no wetness or scent of insulin, where as may indicate the cannula has dislodged.Checking your blood glucose 7 / page 96.Warning: test results greater than 13.9 mmol/l mean high blood glucose (hyperglycemia).Warning: if you get results below 3.9 mmol/l or above 13.9 mmol/l, but do not have symptoms of hypoglycemia or hyperglycemia (see chapter 9, living with diabetes), repeat the test.If you have symptoms or continue to get results that fall below 3.9 mmol/l or above 13.9 mmol/l, follow the treatment advice of your healthcare provider.
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