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