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 12/01/2023

Event Type  Injury  

Event Description

On 12/4/23 a beta bionics clinical diabetes specialist (cds) stated a patient reported to her via email of a severe hypoglycemic event.The exact date of the event is unknown, but it occurred around (b)(6) 2023.The patient reported: "at night my fiancé hears the dexcom alarm and wakes me and i haven't checked insulin on board.But at one point i was "very low" for over 2% of past two days.Several times during day i passed out my sugar was so low at night he really struggled to wake me, which is not common, so it is definitely going very low." the night the patient's blood glucose (bg) went low, her fiancé gave the patient a glucagon shot because the patient lost consciousness.The patient regained consciousness after the glucagon was injected and was okay after.The patient did not have a diabetic seizure.No emt/firefighters were needed.The cds reported the patient has increased her bg target to higher.The cds has reviewed the following topics with the patient since her training: importance of meal announcements, not announcing fake carbs, not taking injections and not overtreating low bg with carbs to avoid hypoglycemia and ilet algorithm maladaptation.

Manufacturer Narrative

No product was returned for evaluation.The ilet logs were reviewed by beta bionics failure investigation department.Based on the engineering logs, the ilet is behaving as intended.The ilet logged an expired continuous glucose monitor (cgm) sensor and referenced its last valid blood glucose (bg) reading of 140mg/dl.Due to this reading, the ilet continued to request basal deliveries of approximately 0.06 units of insulin.Basal deliveries were continued until cgm signal was reestablished.After reconnection to the cgm transmitter, the ilet was found to adjust/pause basal deliveries based on bg values it was receiving.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.

• 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: 18314529
• MDR Text Key: 330329016
• Report Number: 3019004087-2023-00020
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/12/2023

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: 12/04/2023
• Initial Date FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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): Required Intervention
• Patient Sex: Female