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, 17845-5a-aw rev b 09/17; checking your blood glucose, chapter 4 / page 36.Warnings: test results below 70 mg/dl mean low blood glucose (hypoglycemia).Test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia (see "living with diabetes" on page 115), 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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It was reported that a patient's blood glucose (bg) levels reached 404 mg/dl while wearing the pod between 24 and 36 hours.When removed from the infusion site (arm), the pod's cannula was found bent straight up in the air and patient "smelt" and felt insulin on the skin.As treatment, a new pod was applied.Patient discarded the pod so device is not available for return.
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