The device was not returned for evaluation.We are unable to confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.Omnipod insulin management system ¿ user guide model: ust400 14421-aw rev h 01/16 checking your blood glucose 7 / page 96: warning: test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).Warning: if you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia, repeat the test.If you have symptoms or continue to get results that fall below 70 mg/dl or above 250 mg/dl, follow the treatment advice of your healthcare provider.
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