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 blood glucose level rose to around 360 mg/dl while wearing the pod less than an hour.Bleeding, pain, and swelling at the infusion site were also reported.The patient reported being unsure if the cannula was properly seated in the infusion site (arm).As treatment, the pod was removed and a new pod was applied.
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