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 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.
|
On 12/25/2023, a beta bionics clinical diabetes specialist (cds) reported during a follow-up call an ilet patient reported she was in the hospital due to a severe low blood glucose (bg) event.The patient reported on (b)(6) 2023 she "fell asleep" in the bathroom so her husband called 911.The patient does not remember falling asleep.The patient reported when the ems arrived her bg was at 29 mg/dl.It is unknown what treatment the patient received by the ems and at the hospital.The patient removed the ilet and is back on manual injections.On 12/26/2023, the cds followed-up with the patient.The patient has been discharged from the hospital and is doing well.The cds and the patient scheduled a re-training for on (b)(6) 2024.Ilet log data from on (b)(6) 2023, was reviewed by beta bionics.It was discovered that from 6:38pm - 8:39pm the patient announced 3 separate meal boluses of 3.1 units while her bg was in the 40's mg/dl or below.On (b)(6) 2024, the cds assisted the patient with restarting on the ilet.During the re-training the patient reported she did not disconnect the infusion set from herself when changing her insulin cartridge.As a result, the patient primed herself with insulin during the fill tubing process.The patient is unsure how much insulin went into her body.Consequently, this may have also contributed to the patient's severe hypoglycemic event on (b)(6) 2023.The cds reviewed with the patient all items on the training checklist with special emphasis on hypoglycemia and appropriate treatment.The patient is currently back on the ilet and doing well.
|