It was reported that the patient had been hospitalized with hyperglycemia.The patient's blood glucose levels rose above 500 mg/dl while wearing the pod between 5 and 24 hours on the leg.Symptoms reported include hyperglycemia, lungs burning and blood hyperacidity, the patient was treated with 9 liters of water infusion, pain killers and humana insulin, the pod was removed at the hospital.The patient was released after 6 days.
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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.No lot release records were reviewed, as the product lot number was not provided.
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