No product was returned for evaluation.The ilet logs were reviewed by beta bionics failure investigation department.No product performance issues were identified.If the product is received at a later date, the complaint will be reopened and investigated accordingly.No anomalies were observed.The device history record (dhr) review was completed, and this device passed all manufacturing release criteria for distribution.There were no issues identified that would have impacted this event.
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On 12/28/2023, a beta bionics clinical diabetes specialist (cds) reported an ilet patient experienced a severe hypoglycemic event on (b)(6) 2023.Per the patient, she first experienced hyperglycemia on (b)(6) 2023 due to a bent infusion set cannula.The infusion set was changed, and insulin delivery resumed.The patient then went to bed.Then, sometime in the morning on (b)(6) 2023, the patient's blood glucose (bg) went low, and the patient lost consciousness.The patient's husband called ems and when they arrived on scene they took the ilet off the patient.The patient was transported to a hospital.The patient is unsure what her bg went down to.The patient is also unsure what ems administered but did mention "some sort of iv." the patient was released from the hospital on (b)(6) 2023.The patient is currently still off the ilet and is using backup insulin therapy.Ilet log data from on (b)(6) 2023 was reviewed by beta bionics.Leading up to the event, the patient's bg was decreasing from above 400mg/dl at 2:45am and reached 107mg/dl at 4:30am.Throughout this time, the ilet was continuously requesting basal deliveries of insulin every 5 minutes.At 4:30am, the ilet ceased basal delivery.The patient's bg continued to decrease until 6:45am where it began to increase.The patient had been on the ilet for over two months.The patient had recently factory reset her ilet on friday on (b)(6) 2023.Before the factory reset, the patient was experiencing glycemic variability.The patient was inconsistent with meal boluses and had been experiencing some hypoglycemia.The patient would often over treat her hypoglycemia.On (b)(6) 2023, the cds had spoken with the patient and raised her daytime bg target to usual, instructed the patient to announce usual size meal boluses, and reviewed the proper treatment of hypoglycemia.
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