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 12/19/2023

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 12/20/23 an ilet patient reported he was driving on 12/19/2023 at around 4:20-4:30pm.The patient noticed his blood glucose (bg) levels drop from 136mg/dl down to 32mg/dl rapidly.The patient stated he lost consciousness while driving and woke up in the hospital.During his hospital visit, he was administered an iv drip of glucagon.The patient was able to get discharged that evening of (b)(6) 2023.The patient is currently not using the ilet and will return using his previous insulin pump.

• 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: 18456625
• MDR Text Key: 332211314
• Report Number: 3019004087-2024-00005
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2024

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
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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): Hospitalization
• Patient Sex: Male