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); Convulsion/Seizure (4406)

Event Date 12/11/2023

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 (b)(6) 2023 a (b)(6) diabetes specialist (cds) reported she received a text from a patient stating that over the past 2 weeks the patient has had 2 extremely low blood sugar (bg) events that have led to convulsions and the patient's wife having to call the paramedics each time.One event occurred on 12/11/23 and the other event occurred on 11/29/23.The hypoglycemic event that occurred on 12/11/23 will be reported on manufacturer report number 3019004087-2024-00001.The hypoglycemic event that occurred on 11/29/23 will be reported on manufacturer report number 3019004087-2024-00002.On 12/11/23 the patient reported his bg got to 41 mg/dl and the paramedics were called at 7:04pm.The emt administered glucagon gel packs to the patient.Leading up to the even the patient only remembers that he had not eaten for about 4 hours and nothing out of the ordinary had occurred.The cds will review the patient's ilet data and will continue to monitor the patient's bg closely.The cds will have the patient monitor his bg closely as 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: 18432612
• MDR Text Key: 331861735
• Report Number: 3019004087-2024-00001
• Device Sequence Number: 1
• Product Code: QJI
• UDI-Device Identifier: 850050080015
• UDI-Public: (01)850050080015
• Combination Product (y/n): N
• PMA/PMN Number: K22224
• 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: 01/02/2024

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: 12/12/2023
• Initial Date FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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
• Patient Sex: Male