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 11/15/2023

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 an ilet patient's mother reported that the patient experienced a hypoglycemic event on (b)(6) 2023.The patient had a severe low blood glucose (bg) of 19 mg/dl.The patient needed assistance from their mother in administering glucose tablets to bring their bg back in range.The patient disconnected from the ilet.The patient stated they have the most trouble with low blood glucose (bg) levels and they tend to go low around 3 am every night.Also, when the patient eats a meal and announces a meal bolus, their ilet takes them low.The patient eats similar amounts of carbohydrates with every meal.The patient's mother stated that their dexcom continuous glucose monitor (cgm) transmitter could have been an issue.The patient and their mother think that the transmitter was acting up.The patient stopped using the dexcom g6 cgm as well.The patient and mother stated they will work with their beta bionics clinical diabetes specialist (cds) to get reconnected to the ilet.On (b)(6) 2023 the cds assisted the patient in reconnecting to the ilet.The patient is 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: 18271322
• MDR Text Key: 329774177
• Report Number: 3019004087-2023-00017
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2023

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: 11/20/2023
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• 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: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR (CGM)
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose