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); Confusion/ Disorientation (2553)

Event Date 01/06/2024

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.The ilet engineering logs were reviewed by beta bionics failure investigation department.Data matching complaint description was found on 2024-01-06: -all alert settings were found to be at factory setting (all on) and volume was found to be set to "high." cgm glucose reported by a cgm transmitter to the ilet at the start of the day (12:02am) is at 90mg/dl.Cgm glucose increases and reaches 184mg/dl at 4:07am.-logs indicate that the ilet was requesting insulin deliveries every 5-15 minutes.Each delivery request was between 0.04 - 0.3 units of insulin.5:52am - cgm glucose = 251mg/dl.-ilet was requesting insulin every 5 minutes.8:32am - cgm glucose = 362mg/dl.-alert 23 (high glucose) was triggered.-delivery requests made by the ilet were found to have increased to 0.2 - 0.6 units per request.8:45am - cgm glucose = 365mg/dl.-alert 23 status updated to "acknowledged." -cgm glucose values then begin to decrease.10:27am - cgm glucose = 248mg/dl.11:16am - cgm glucose = 184mg/dl.-a "usual" sized lunch meal announcement is recorded requesting 2.465 units of insulin.Motor activity indicates that the insulin motor had successfully moved the equivalent of 2.4689 units of insulin.12:07pm - cgm glucose = 253mg/dl.-ilet was found requesting insulin deliveries every 5 minutes.-request sizes increased every 5 minutes from 0.055 units at 11:24am to 1.625 units at 11:59am before decreasing to 1.16 units at 12:09pm.1:09pm - cgm glucose = 307mg/dl.-ilet was found requesting insulin every 5 minutes.-request sizes ranged from 0.2 to 1.2 units of insulin.-last delivery of insulin prior to the event was 1.28 units at this time.-alert 35 (insulin occlusion) was triggered at this time and not marked at "acknowledged." no further insulin delivery requests were made by the ilet for this date due to alert 35 remaining activated.Cgm glucose values begin to decrease.After 1:22pm, cgm glucose values begin decreasing at a rate of at least 2mg/dl per minute.1:37pm - cgm glucose = 234mg/dl.1:52pm - cgm glucose = 154mg/dl.2:07pm - cgm glucose = 86mg/dl.-alert 24 (glucose falling quickly) is triggered.2:12pm - cgm glucose = 69mg/dl.-alert 22 (low glucose) is triggered.-alert 21 (urgent low soon) is triggered.3:17pm - cgm glucose = 51mg/dl.-alert 20 (urgent low glucose) is triggered.3:37pm - cgm glucose = 53mg/dl.4:02pm - cgm glucose < 40mg/dl.4:47pm - cgm glucose = 42mg/dl.5:12pm - cgm glucose rises to = 118 mg/dl.-alert 20 (urgent low glucose) is deactivated.-no alert statuses were found to be updated to "acknowledged." 5:22pm - cgm glucose = 96mg/dl.5:27pm - cgm glucose = 63mg/dl.-alert 22 (low glucose) is triggered.5:32pm - cgm glucose = 53mg/dl.-alert 20 (urgent low glucose) is triggered.6:12pm - cgm glucose = 139mg/dl.-alert 20 (urgent low glucose) is deactivated.-alert was never updated to "acknowledged." 8:42pm - cgm glucose = 186mg/dl.-ilet is unable to request insulin due to alert 35 remaining active and never "acknowledged." 9:57pm - cgm glucose = 252mg/dl.-ilet is unable to request insulin due to alert 35 remaining active and never "acknowledged." 10:37pm - cgm glucose = 305mg/dl.-ilet is unable to request insulin due to alert 35 remaining active and never "acknowledged." 11:57pm - cgm glucose = 395mg/dl.-ilet is unable to request insulin due to alert 35 remaining active and never "acknowledged." based on the logs, the ilet is not malfunctioning.The ilet appropriately triggered cgm glucose related alerts and was adjusting insulin dose sizes based on cgm glucose values it was receiving.The last delivery request the ilet was able to make was for 1.28 units of insulin paired with a cgm glucose value of 307mg/dl.1 hour later, cgm glucose values were below 100mg/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 1/7/24 a beta bionics clinical diabetes specialist (cds) received a text message from an ilet patient that he was in the hospital due to a low blood glucose (bg) event.The event occurred on (b)(6) 2024.The patient stated: "hi (cds), i'm actually in the hospital; yesterday my wife found unconscious and the paramedics said my glucose was 19.Might have fractured a rib from cpr.Take care." the cds requested a follow-up call with the patient to discuss the event.The patient stated he can do a follow-up after he's been released from the hospital.On (b)(6) 2024 the cds had a follow-up call with the patient's healthcare provider (hcp).The hcp stated they met with the patient on (b)(6) 2024 via an inpatient visit.The patient told his hcp on friday evening ((b)(6) 2024) he changed his insulin cartridge and infusion set.On saturday ((b)(6) 2024), he ate breakfast that was high in carbohydrate content and did not announce his meal.He then ate lunch and announced it as a usual lunch.His hcp noted that the lunch meal was somewhat lower in carbohydrates than his typical lunch.After lunch, the patient as out running errands, his bg started dropping and he began receiving alerts from the ilet.He did not have hypoglycemia treatment on him, so he decided to drive home.His hcp was unsure of how long the drive home was.When he got home, he reported having two bottles of juice.His bg came back up and then dropped again.He stated he was "very fuzzy" during this time and remembers laying down.His next memory was the paramedics at his home.The hcp was able to confirm that his wife found him unconscious and called ems.The hcp also confirmed that cpr was not administered, and the patient had not taken any outside insulin injections.

• 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: 18655701
• MDR Text Key: 334721878
• Report Number: 3019004087-2024-00015
• 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: 02/06/2024

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: 01/07/2024
• Initial Date FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2023
• 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