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 Bone Fracture(s) (1870); Hypoglycemia (1912)

Event Date 10/18/2023

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 (b)(6) 2023, an ilet patient's husband called in reporting that the patient has had a couple severe low blood glucose (bg) episodes, one in which the patient fell and broke her ankle.The beta bionics customer care agent confirmed that the patient is currently in stable condition and her bg levels are within range.No exact date was provided of the severe hypoglycemic events as these episodes occurred at different times over the past month of the patient using the ilet.The patient's husband indicated that patient has hypoglycemic unawareness and stated during the latest sever hypoglycemic episode in which the patient had fallen and broken her ankle, the patient's husband had to administer a glucagon injection to the patient.The patient's husband said the patient did not take any insulin outside of the ilet and the patient did not eat a meal nor deliver a meal announcement bolus previous to the low.On (b)(6) 2023, the patient spoke with a clinical diabetes specialist (cds) about the severe hypoglycemic event.The patient stated she has some hypoglycemia unawareness and she passed out and ended up breaking her ankle.The cds reviewed the patient's ilet log data.The report showed there were multiple lunch and dinner meal announcement boluses in a short space of time.The cds and patient discussed meal announcement bolus etiquette and that meal announcements are only to be done when the patient is actually eating and not as a correction to high blood glucose.The cds and the patient discussed how misuse of meal announcements can maladapt the algorithms of the ilet.The patient stated she would work on this.The cds and the patient set up a time to meet in 1 week.On (b)(6) 2023 the patient and the cds met in person and reviewed the ilet log report.The patient stated she has been much better since the previous meeting.The patient's ilet report showed the patient is only announcing up to 1 time daily for each meal.The cds and patient also discussed allowing the ilet to have a soft landing for hypoglycemia and how this can also help the ilet to adapt.The patient loved being able to see the ilet data and it helped her to understand why she cannot try to correct on her own.

• 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: 18062483
• MDR Text Key: 327248240
• Report Number: 3019004087-2023-00012
• Device Sequence Number: 1
• Product Code: QJI
• UDI-Device Identifier: 850050080015
• UDI-Public: (01)850050080015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2023

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: Not provided
• Initial Date FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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