The product was not returned for evaluation.The user reported the cannula was not inserted correctly into the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.The omnipod¿s user guide warns to "check the infusion site after insertion to ensure that the cannula was properly inserted.The pdm will automatically remind you to check your blood glucose 1.5 hours after each pod change.If the cannula is not properly inserted, hyperglycemia may result.Verify there is no wetness or scent of insulin, which may indicate the cannula has dislodged,¿ ¿because insulin pods use only rapid-acting insulin, users are at increased risk for developing hyperglycemia (high blood glucose) if insulin delivery is interrupted,¿ and ¿test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results above 250 mg/dl, but do not have symptoms of hyperglycemia, repeat the test.If you have symptoms or continue to get results above 250 mg/dl, follow the treatment advice of your healthcare provider.¿ lot release records were reviewed and the product lot met all acceptance criteria.
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