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 er visit, skin irritation and hyperglycemia.No lot release records were reviewed, as the product lot number was not provided.
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It was reported that the patient visited the emergency room (er) due to skin irritation such as blisters and high blood glucose (bg) levels >500 mg/dl, while wearing the pod on the abdomen.At the hospital, the patient was prescribed antibiotics (thromycin 250mg) to treat an ear infection and be taken 2 pills 4 times a day for 7 days, skintac to be used at the site before placing the pod, mediderma cream, pariton was suggested to get rid of the itchiness (one pill a day) until the problem solves and manual insulin injections using a pen were administered to treat the hyperglycemia.
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