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 and the hospital visit.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod 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 that fall above 250 mg/dl, follow the treatment advice of your healthcare provider.".
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Customer was in the hospital for a different reason when high blood glucose values were reported.She reported her blood glucose and insulin history is as follows: time: 9:30 pm, blood glucose (mg/dl): 436, insulin: bolus 2.20u.They gave him a manual injection of insulin.
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