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); Convulsion/Seizure (4406)

Event Date 01/09/2024

Event Type  Injury  

Event Description

On (b)(6) 2024 a beta bionics clinical diabetes specialist (cds) received a phone call from an ilet user that he was hospitalized for a low blood glucose (bg) event.The user was hospitalized on (b)(6) 2024.On (b)(6) 2024 the cds had conducted a follow-up with the user where the ilet was factory reset and he was re-educated on proper management of hyperglycemia and hypoglycemia on the ilet.On (b)(6) 2024 the user reported he announced a meal bolus around 5:30pm and he saw his bg trending down.Once his bg got to around 100 mg/dl, he began treating.The user's bg then went to 333 mg/dl.Then he saw his bg was 90 mg/dl with 2 arrows down, so he disconnected from ilet.The user reported his bg "plummeted" within 30 minutes and continued to treat with a large amount of carbohydrates.When he saw his bg was at 41 mg/dl, he called ems.He reports he blacked out at this time and had a seizure.Ems administered dextrose and he became alert.The user was discharged from the hospital on (b)(6) 2024 and doing well.He is currently home and doing well.This user was recently hospitalized back in december due to severe hyperglycemia from over treating a low glucose (mfr report#: 3019004087-2024-00003).The user has multiple medical issues including poorly controlled type 1 diabetes (a1c prior to starting the ilet was 12%) and on hemodialysis.His hcp is aware that use of the ilet in individuals on dialysis is considered off-label.After the first event in december, the cds spoke with the healthcare provider and strongly recommended the user discontinue ilet use.Additionally, the cds and hcp's office had multiple points of contact to provide re-education and support to the user as he struggled to adjust to pump therapy and was not consistently adhering to best practices for managing highs and lows on the ilet.After the second event in (b)(6) 2024, the cds spoke with the patient's healthcare provider (hcp) and reinforced that the patient should discontinue ilet use and to our knowledge he is no longer using the ilet.The cds had asked the patient to sync his data once discharged so that we can obtain his engineering logs and review the data related to the event, but this has not been done to date.

Manufacturer Narrative

No product was returned for evaluation.The ilet engineering logs could not be reviewed by the beta bionics failure investigation department as no data is available for the event timeframe.The engineering logs for this device ends at 12/16/2023.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.

• 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: 18682296
• MDR Text Key: 335075380
• Report Number: 3019004087-2024-00017
• Device Sequence Number: 1
• Product Code: QJI
• 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: 02/09/2024

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: 01/10/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2023
• 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): Required Intervention; Hospitalization
• Patient Sex: Male