The device was not returned for evaluation.The cannula had dislodged from the infusion site.This condition could interrupt insulin delivery and contribute to 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.Changing your pod.Chapter 3 / page 34.Warnings: check often to make sure the pod and soft cannula are securely attached and in place.A loose or dislodged cannula may interrupt insulin delivery.Verify that there is no wetness or scent of insulin, which may indicate that the cannula has dislodged.If you observe blood in the cannula, check your blood glucose frequently to ensure that insulin delivery has not been affected.If you experience unexpectedly elevated blood glucose levels, change your pod.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 levels reached 350 mg/dl while wearing the pod between 4 and 24 hours.While "taking a bath," the pod fell off, thus, cannula dislodged from the infusion site (abdomen).
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