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 12/22/2023

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 reported they had a hypoglycemic seizure earlier in the day around 1pm eastern time.The patient's wife immediately gave the patient a glucagon shot.The patient continued seizing for about 20 minutes.The patient reported before the seizure the ilet indicated their blood glucose (bg) was at 70mg/dl with the arrow trending upwards.The patient estimated their actual bg was 40 mg/dl.Following the seizure, the patient stated they saw a low battery alert for their dexcom g6 continuous glucose monitor (cgm).The patient called dexcom and after troubleshooting they discovered that the dexcom sensor was faulty and giving false readings of about 40mg/dl higher than the actual finger stick readings.The patient asked what they can do to counteract this issue.The customer care agent stated it is extremely important that the cgm read accurately or the ilet will act on incorrect readings.The agent also advised the patient to finger check their bg if they ever feel like the readings may be a bit off.The patient stated they will be talking with their doctor about possibly switching off the ilet as a result of being very scared an incident like this could occur in the middle of the night.The patient's bg levels were back in range, but they needed help pairing the new cgm transmitters and sensor.The agent and patient were able to do so and see bg levels on the ilet screen again.On (b)(6) 2023 the patient reported they disconnected from the ilet, and they are going back to their old 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: 18499663
• MDR Text Key: 332723073
• Report Number: 3019004087-2024-00009
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2024

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: 12/22/2023
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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: Male