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 confirm the reported leaking battery.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.
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A technical assessment of the device design identified the root cause of the thermal event to be the dash pdm charging voltage exceeding the battery specification, defined as overcharging.Field safety corrective action has been initiated by insulet corporation.No battery fluid residue was observed in the pdm.The battery was observed to be swollen.However, this battery swelling did not result in a fluid leak.
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