The product was not returned for evaluation.The user reported that the cannula had pulled out of the infusion site.A dislodged cannula could interrupt insulin delivery and may lead to hyperglycemia.The omnipod¿s user guide warns to "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 there is no wetness or scent of insulin, where as may indicate the cannula has dislodged," "because insulin pods use only rapid-acting insulin, users are at increased risk for developing hyperglycemia (high blood glucose) if insulin delivery is interrupted," and "test results greater than 13.9 mmol/l [250 mg/dl] mean high blood glucose (hyperglycemia).If you get results above 13.9 mmol/l [250 mg/dl], but do not have symptoms of hyperglycemia, repeat the test.If you have symptoms or continue to get results above 13.9 mmol/l [250 mg/dl], follow the treatment advice of your healthcare provider." no product lot number was reported therefore no qualification records were reviewed.
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