The product was not returned for evaluation.We are unable to confirm the reported failure of the needle mechanism to fire and deploy the cannula or to determine its root cause.Lot release records were reviewed and the product lot met all acceptance criteria.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," 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.".
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