MAUDE Adverse Event Report: BETA BIONICS ILET BIONIC PANCREAS; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Model Number BB1001

Device Problem Use of Device Problem (1670)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 12/21/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ILET BIONIC PANCREAS
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): BETA BIONICS; 11 hughes; irvine CA 92618
• Manufacturer (Section G): BETA BIONICS; 11 hughes; irvine CA 92618
• Manufacturer Contact: joe conkey ; 11 hughes; irvine, CA 92618
• MDR Report Key: 18548135
• MDR Text Key: 333314872
• Report Number: 3019004087-2024-00011
• Device Sequence Number: 1
• Product Code: QJI
• UDI-Device Identifier: 850050080015
• UDI-Public: (01)850050080015
• Combination Product (y/n): N
• PMA/PMN Number: K232224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BB1001
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2023
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female