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 released records were reviewed and the product lot met all acceptance criteria.The mylife omnipod user guide warns "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," 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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