Omnipod DASH Insulin Management System

Description of Event or Problem

It was reported by a healthcare professional through an MHRA user report (MHRA reference number (b)(4)) that a patient experienced hypoglycemia on an unspecified date while on a flight. Since multiple instances were reported together, it is unclear if the patient required medical intervention. Therefore, this event has been reported in caution. No further information has been provided at the time of this report. At this time there is insufficient information to determine if Insulet's device caused or contributed to the reported event. Additional information has been solicited, and a supplementary report will be filed if received. This is one of 8 reports (Insulet reference number (b)(4)).

Additional Manufacturer Narrative

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 event. No Lot Release records were reviewed, as the product lot number was not provided.