The product was not returned for evaluation.We are unable to determine if any product malfunction or other product condition could have contributed to the reported hypoglycemia, hyperglycemia and er visit.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod¿s user guide warns " 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, and "test results below 70 mg/dl mean low blood glucose (hypoglycemia).If you get results below 70 mg/dl, but do not have symptoms of hypoglycemia, repeat the test.If you have symptoms or continue to get results that fall below 70 mg/dl, follow the treatment advice of your healthcare provider,¿ and it advises "hypoglycemia can occur even when a pod is working properly.Never ignore the signs of low blood glucose (no matter how mild).If left untreated, severe hypoglycemia can cause seizures or lead to unconsciousness.If you suspect that your blood glucose level is low, check your bg level to confirm.".
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