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.
|
It was reported that a patient's blood glucose levels exceeded 600 mg/dl while wearing the pod unknown duration of time.While "outside at a baseball tournament," the pod fell off, thus, cannula dislodged from the infusion site (unknown).A new pod was applied immediately after the event.
|