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 bent and 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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