We are unable to determine if any product condition could have contributed to the reported er visit and hyperglycemia.It was reported that 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.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.
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It was reported that the patient visited the emergency room (er) due to high blood glucose (bg) levels of 400 mg/dl and ketones, while wearing the pod on the abdomen between 36 and 48 hours.The cannula had dislodged from the infusion site.At the hospital, the patient was administered 50 units of insulin and fluids.
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