According to the complainant the device will not be returned for investigation.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 the patient's blood glucose level (bg) rose to 450 mg/dl while wearing the pod between 1 and 4 hours.The pod reportedly tearing away from adhesive backing the infusion site (abdomen), causing the cannula to dislodge.As treatment, the mother stated the daughter was able to apply a new pod.
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