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 skin irritation.No lot release records were reviewed, as the product lot number was not provided.
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It was reported that after wearing the pod on the abdomen between 24 and 36 hours, the site was badly irritated, forcing the patient to go back to manual insulin injections.The patient contacted the doctor over the phone, who prescribed a cream (name unspecified) to treat the affected area.
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