According to the complainant the device will not be returned for investigation.The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.No lot release records were reviewed, as the product lot number was not provided.
|
It was reported the patient's blood glucose level read high (>500 mg/dl) while wearing the pod between 1 and 4 hours.When removed from the infusion site (hip/buttocks), the pod's cannula was found to be dislodged.As treatment, the patient administered insulin and applied a new pod.
|