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 had been hospitalized with hyperglycemia.The patient's blood glucose levels reached 329 mg/dl while wearing the pod between 24 and 36 hours.Symptoms reported include that the patient could not see, speak properly and their right hand kept dropping things.The patient was diagnosed with a stroke with brain damage that affected their right side.At the hospital the doctors performed an ekg, mri and other tests that were not disclosed.The patient was given intravenous therapy of fluids.The patient was prescribed xarelto (20mg) and was released the following day.The pod was removed at the hospital.
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