The product was not returned for evaluation.We are unable to confirm the bent cannula or to determine if it could have contributed to the hyperglycemia.The user also reported that the cannula was out of the infusion site.This condition could potentially interrupt insulin delivery and may lead to hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod user guide warns "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 that 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 that fall above 250 mg/dl, follow the treatment advice of your healthcare provider.".
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