The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to determine if any product condition could have contributed to the reported hospitalization 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 hospital and was diagnosed with blood glucose (bg) values reached 487 mg/dl.The patient had dizziness, blurred vision, and thirst.For treatment, the patient was given fluids.The patient was discharged after 3 hours.The pod was worn between 4 and 24 hours on the back.
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