The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.It was reported the cannula was possibly not inserted correctly into 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's glucose exceeded 250 mg/dl, while wearing the pod between 5 and 24 hours on the abdomen.Upon inspection, it was noticed that the pod was leaking, and the patient was unsure if the cannula was properly inserted into the skin.A new pod was applied to treat the hyperglycemia.
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