The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to the reported hospitalization for hyperglycemia.Generally adhesion issues are due to variations in skin condition and are not considered malfunctions.No lot release records were reviewed, as the product lot number was not provided.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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