MAUDE Adverse Event Report: BETA BIONICS ILET BIONIC PANCREAS; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Model Number BB1001

Device Problem Use of Device Problem (1670)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 11/14/2023

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 12/24/23 a beta bionics clinical diabetes specialist (cds) reported she discovered for the first time that an ilet patient had an auto accident on (b)(6).2023 related to a hypoglycemic event.The cds reported that the patient and the patient's healthcare provider (hcp) were vague with details of the event.The patient does not recall much about the accident other than driving, losing consciousness and then waking up to ems.The patient was taken to the hospital, but it is unknown if the patient was admitted or discharged from the emergency room.It is also unknown what treatment the patient received.The cds asked the patient to sync his ilet with the mobile app so the ilet data can be reviewed.Ilet log data from 11/14/23 was reviewed by beta bionics and the patient's blood glucose (bg) values reported to the ilet by a continuous glucose monitor (cgm) transmitter were found to be below 75mg/dl for about 2.5 hours (5:15pm - 7:35pm).The last basal delivery the ilet requested prior to the event was at 4:51pm with a reported bg of 85mg/dl trending downwards.Alert 22 (low glucose) is triggered at 5:15pm with a bg reading at 72mg/dl.Alert 21 (urgent low soon) is triggered at 5:40pm with a bg of 60mg/dl.Alert 20 (urgent low glucose) is triggered at 5:50pm with a bg of 51mg/dl.None of the low glucose alerts were acknowledged by the patient.No insulin was requested during the duration of the low event.The total time the patient's bg was less than 54 mg/dl was 25 minutes.The patient's bg begins to increase after 7:25pm and is above 75mg/dl at 7:35pm.The ilet begins requesting basal deliveries again at 7:51pm with a bg of 132mg/dl and increasing.This is followed by a "usual" sized dinner bolus announcement at 8:02pm.Of note, on 11/9/23 the audio settings menu was opened, and the audio level was set to "off." no alert setting changes were logged after 11/9/23.All bg related alerts were triggering appropriately.No malfunction alerts were found in the logs either.The patient has not been wearing the ilet since the event on 11/14/23.

• 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: 18547354
• MDR Text Key: 333285281
• Report Number: 3019004087-2024-00010
• 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: 01/18/2024

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: 12/24/2023
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• 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