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

Model Number BB1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/26/2023

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 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.

Event Description

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.

• 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: 18549371
• MDR Text Key: 333315284
• Report Number: 3019004087-2024-00012
• 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: 01/21/2024

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: 12/28/2023
• Initial Date FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• 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
• Treatment: CONVATEC INSET (23", 6MM) INFUSION SET.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female