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 Problem Hypoglycemia (1912)

Event Date 11/04/2023

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 beta bionics clinical diabetes specialist (cds) reported she received an email from a patient's healthcare provider (hcp) regarding an ilet patient.The hcp stated the patient experienced a severe hypoglycemic event on (b)(6) 2023.Per the hcp's report, on saturday, (b)(6) 2023, the patient ate breakfast at 11:30am and gave himself a usual meal bolus.The patient's blood glucose (bg) then begins to drop.The patient did not have his phone with him at the time, so the patient did not receive any alerts but reports feeling bad.The ilet showed the patient's bg was at 70 mg/dl.It is reported the patient's bg fell to 32 mg/dl and emergency medical services (ems) were contacted.At this time, the patient's cognitive status during this event is unknown.It is also unknown what treatment, if any, the patient received from ems to correct his low bg.Multiple attempts to contact the patient directly to obtain further details about this event have been unsuccessful.

• 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: 18242831
• MDR Text Key: 329429513
• Report Number: 3019004087-2023-00014
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2023

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: Not provided
• Initial Date FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• 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