Omnipod 5 Pod

Description of Event or Problem

The patient reported they went to the Emergency Room (ER) with hypoglycemia on (b)(6) 2026. The patient's blood glucose levels declined to approximately 50 mg/dL while wearing the Pod between 24 and 36 hours on their leg. The patient noted the Pod gave her too much insulin. Symptoms reported include vomiting, feeling really off and trouble with speech. Prior to the ER, the patient had glucose tablets and candy to try and raise their BG level. The patient mentioned by the time they were seen in the ER, their BG level rose to 300 mg/dL. The patient was diagnosed with diabetic low and treated with intravenous fluids. The patient was released 6 hours later the same day.

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. ate.Locked Down Smartphone: PHONE_CONTROL_IOS:Omnipod Software App Version: 2.2.1,Operating System: 26.5,Hardware: iPhone15.2,CGM Sensor Type: Dexcom G6.Please 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.