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 12/29/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 a beta bionics clinical diabetes specialist (cds) was sent a text message from an ilet patient's mother stating the patient experienced a severe hypoglycemic event.The event occurred on friday, (b)(6) 2023.The mother reported at 6:45pm the patient's blood glucose (bg) dropped after having a whole box of popcorn.The patient did not give a meal bolus.The mother reported the patient's bg decline was slow, not steep.When the patient's bg reached 86 mg/dl he ate a pack of gummies.Ten minutes later the patient's bg reached 64 mg/dl and the patient ate another pack of gummies.Then the patient's dexcom continuous glucose monitor (cgm) read 50 mg/dl and the patient started seizing.The patient's mother then gave him a gvoke glucagon shot.The patient was taken to the emergency room and admitted to the hospital.The mother stated this was the first time the patient ever had a seizure and as a result suspects the cgm may also have been incorrect.The mother reported the ilet appeared to have given the patient 30 units of basal.She stated this was not right as the patient should only have been given 18 units.The patient was disconnected from the ilet.Beta bionics reviewed the patient's ilet report.Prior to the low event, the patient announced a less lunch at 1:26pm (9.6 units).After that, the ilet continues to dose basal.Additional insulin for correction is not given until the patient's bg starts to rise again around 4pm.As the cgm trended downward, insulin dosing was stopped completely from 2:41pm to 3:11pm (30 minutes).Then, the bg stabilizes between 96-100 mg/dl and the ilet doses some basal as needed until the cgm hits 83 mg/dl at 6:41pm when dosing stopped.The patient's bg hit 72 mg/dl at 6:46 pm, then 64 mg/dl at 6:51pm, 58 mg/dl at 6:56pm and 66 mg/dl at 7:01pm.At 7:06 pm the cgm read 88 mg/dl and trending up.On (b)(6) 2024 the patient's mother reported after speaking with their endocrinologist they decided to continue using the ilet.On (b)(6) 2024 the patient's mother contacted beta bionics and reported they are returning the ilet.

Manufacturer Narrative

Upon review of the ilet report by beta bionics medial affairs, it is unclear as to why the patient seized.The patient's cgm data shows the patient's bg was low for 20 minutes, no cgm points less than 54 mg/dl and treatment was given at 86 mg/dl and 64 mg/dl.A possibility is the cgm may have been inaccurate, and the low treatment could not catch the falling bg in time.However, the allegation of the cgm being inaccurate could not be confirmed.The low treatment at 86 mg/dl and 64 mg/dl should have raised his glucose.The ilet report showed the patient has had other low bg events (less than 70 mg/dl) that were longer yet did not seize for those.The ilet report also showed the patient is not announcing meal boluses consistently.The patient is relying heavily on the correction algorithm which can result in low bgs.Announcing meals correctly and consistently would help reduce meal excursions and the reliance on the corrections algorithm and may reduce hypoglycemia.Additionally, the ilet report showed over the two weeks prior to the event the patient has been announcing 25% of lunches and 32% of dinners as less.By announcing infrequently, the ilet has less data to learn from.Also, if the patient also announces meals as smaller than they are this can cause the meals to adapt upward.Beta bionics medical affairs recommended a patient retraining with emphasis on proper meal announcement boluses and not prematurely treating or overtreating low bgs.At the time of this report the ilet device has not been received at beta bionics.Also, the ilet engineering logs have not been synced since 12/23/23, which is prior to this event.If the product is received at a later date, the complaint will be reopened and investigated accordingly.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.

• 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: 18610905
• MDR Text Key: 334143023
• Report Number: 3019004087-2024-00013
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2024

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: Health Professional
• 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: 12/31/2023
• Initial Date FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• Is the Device Single Use?: Yes
• 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): Hospitalization
• Patient Sex: Male