Omnipod DASH Insulin Management System

Description of Event or Problem

It was reported the patient's blood glucose level rose greater than 13.9 mmol/L (250 mg/dL) while wearing the Pod between 37 and 48 hours. The adhesive completely separated from the infusion site (Arm) causing the cannula to dislodge. Patient also reported leaking. The patient was able to successfully remove a Pod and apply a new Pod.

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. Lot Release records were reviewed, and the product lot met all acceptance criteria. Locked Down Smartphone: Data not availableOmnipod Software App Version: Data not availableOperating System: Data not availableHardware: Data not availableCGM Sensor Type: Data not availablePlease note, the device identifiers are captured as reported by the complainant and may not align with the device configuration reported in this section as this data is pulled from our Cloud based on the reported date of event.