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 01/02/2024

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.The ilet engineering logs were reviewed by beta bionics failure investigation department.A review of alerts during the week of the reported event found no malfunction alerts prior to 2024-01-02.Investigation into the settings of the device found that the audio of the ilet was listed as "off" as of 2023-08-27.Reviewing the ilet sequence of events leading up to the reported time found that alerts for falling, low, and urgent low soon were triggered appropriately, however no audio notice was emitted by the ilet due to the settings being set to "off.", however the vibratory notification would have triggered regardless of the volume setting.It was not until alert 20 (urgent low glucose) was triggered that the audio setting was overridden and the ilet provided audio feedback.Reviewing bg values sent to the ilet by a cgm transmitter along with ilet insulin basal delivery requests found the following: * 5:34pm - usual sized dinner meal announcement logged requesting 3.915 units of insulin.-bg = 171mg/dl.* 6:50pm - bg rises to 245mg/dl.* ilet is seen requesting basal deliveries for insulin every 5 minutes until 6:59pm -no correction bolus was seen.* 7:00pm - bg decreasing at a rate of at least 2mg/dl per minute.-bg = 225mg/dl.* no delivery requests were made again until 7:34pm * 7:35pm - bg = 175mg/dl.-bg no longer decreasing at a rate of at least 2mg/dl per minute.* ilet requesting basal deliveries every 5 minutes until 7:44pm.-no correction bolus was seen.* 7:45pm - bg decreasing at a rate of at least 2mg/dl per minute.-163mg/dl.* 7:49pm - bg = 145mg/dl.-no delivery request made.* 8:10pm - alert 24 (glucose falling quickly) is triggered.-bg = 93mg/dl and decreasing at a rate of at least 2mg/dl per minute.* 8:20pm - alert 21 (urgent low soon) is triggered.-bg = 75mg/dl.* 8:25pm - alert 22 (low glucose) is triggered.-bg = 69mg/dl.* 9:05pm - alert 20 (urgent low glucose) is triggered.-bg = 50mg/dl.* 9:25pm - bg falls below 40mg/dl.* 10:40pm - ilet stops receiving bg readings.* 10:55pm - connection to cgm transmitter reestablished.-bg = 100mg/dl and increasing.* 11:09pm - ilet begins requesting basal deliveries again.* 11:10pm - bg = 162mg/dl.No product performance issues were identified from a review of the logs.If the device 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.

Event Description

On 1/3/24 a beta bionics clinical diabetes specialist (cds) received a text message from an ilet patient's wife regarding a low blood glucose (bg) event where the patient was transported to the hospital.The cds called the wife, and she explained that the patient was transported to the hospital last night (1/2/24) after having a seizure due to low blood sugar.The emts started the patient on an iv at the patient's home then was transported to the hospital.The patient was treated and is home as of 1/3/24 and is disconnected from the ilet.The patient is currently taking insulin injections.The patient's wife has called the patient's endocrinologist and primary care provider and is awaiting a return call for further instructions.The cds will discuss this incident with the patient's endocrinologist as well.On 1/10/23 the cds held a follow-up zoom call with the patient and wife.Per the patient and wife, on 1/2/24 the patient consumed breakfast and then had a "very physically active day" working on their house.The patient shoveled rocks and moved many items all day.He did not consume lunch.He consumed a "few" light beers during the day.Just before 6pm, the patient and wife went to dinner at chili's.The patient consumed one taco, a ½ cup of black beans, chips and salsa, and 2-3 light beers.He announced a usual dinner.When the patient got home, he moved a large dog crate.He consumed one light beer while relaxing.His blood sugar then dropped.The patient was taking no other insulin other than from the ilet.The cds reviewed the ilet report with the patient.The ilet suspended his insulin at 89mg/dl.The ilet stayed suspended during his low bg.The patient's bg got down to 60mg/dl, the wife gave him treatment, he then his bg got down to 50mg/dl and the patient became disoriented and began to seize.Emts arrived quickly, provided dextrose, and he was hospitalized.The patient also has nerve pain in his back and the seizure made his recovery very painful.The patient's primary care provider and endocrinologist instructed the patient to resume the ilet on friday 1/5/24 and change to a higher target.The patient resumed ilet use and his bg started to drop so he removed the ilet.Following the conversation with the cds, the patient would like to resume the ilet.He will begin at higher target.The cds provided education on carbohydrate consumption with alcohol and physical activity.The patient will keep all of the ilet alarms on and refrain from shutting down his ilet which he had done previously.The cds will follow up with the patient on 1/16/24.

• 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: 18636554
• MDR Text Key: 334492898
• Report Number: 3019004087-2024-00014
• 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: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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