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.The omnipod¿s user guide warns to "check the infusion site after insertion to ensure that the cannula was properly inserted.You should check your blood glucose 1.5 to 2 hours after each pod change and check the infusion site periodically.If the cannula is not properly inserted, hyperglycemia may result.Verify there is no wetness or scent of insulin, where as 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 13.9 mmol/l [250 mg/dl] mean high blood glucose (hyperglycemia).If you get results above 13.9 mmol/l [250 mg/dl], but do not have symptoms of hyperglycemia, repeat the test.If you have symptoms or continue to get results above 13.9 mmol/l [250 mg/dl], follow the treatment advice of your healthcare provider." it also advises "the pdm will also displays a reminder to check the infusion site and cannula.Make sure the pod is securely attached to your skin.You can see the cannula through the small viewing window on the pod." lot release records were reviewed and the product lot met all acceptance criteria.
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