According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization, bent cannula and 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 went to the emergency room (er) and was diagnosed with diabetic ketoacidosis (dka) blood glucose (bg) values reaching 565 mg/dl.For treatment, the patient was given a intravenous (iv) saline solution and diagnostic tests.The patient was vomiting, fatigued and feeling malaise.The canula was bent, while wearing the pod longer than 48 hours on the arm.The pod was discarded and the patient was discharged after 2 days.
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