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 10/23/2023

Event Type  Injury  

Event Description

On (b)(6) /23 a patient reported she just started on the ilet and has had to go to the emergency room twice due to sever hypoglycemia.A clinical diabetes specialist contacted the patient and received further clarification on the reported events.The patient was started on the ilet monday (b)(6) 2023 morning via virtual training.The patient reported she averages about 30 grams of carbs per meal.Per the ilet log report, the patient's blood glucose (bg) was high going into lunch when she announced a usual bolus for lunch.The patient's bg remained elevated and came down into range for some time.Later, the patient announced a dinner bolus while her bg was within range and per ilet report, bgs started rising shortly after.Patient reported eating corn beef with rice for dinner.She then laid down on the couch and fell asleep.The patient reported waking up around 9pm with bgs in the 130s mg/dl with a downward trend.She reported drinking juice at this time.She stated her bg continued to drop to the 90s mg/dl and then 80s mg/dl.At that time, she told her fiancé to get ready to take her to the hospital.Just prior to 10pm when she noticed double arrows down on the dexcom, she drank more juice and self-administered glucagon and reportedly disconnected from the ilet.Her fiancé drove her to the hospital which is about a 6 min drive per the patient.As she was getting out of the car, she reported her leg was "jerking." her fiancé helped her out of the car and they "ran into the er as he yelled for help." according to the patient her dexcom was reading 62 mg/dl upon arrival which was about 10pm.The patient stated her "whole body started jerking" as she arrived at the er.When she was taken to triage her bg by fingerstick was 116mg/dl.Per the patient, the nurse told her this was "normal, she was not hypoglycemic and did not have a need to be in the er." the patient reported being sent home with no intervention or treatment.The patient reported being back home within 15-20 minutes of her hospital visit.By the time she got back home, she stated her bg was up in the 250s mg/dl with double arrows up which is when she decided to re-connect to the ilet.She then went to sleep.Around 1am she reports waking up "sweaty and feeling low." she noticed she was in the 100s mg/dl and dropping.At this point she disconnected from the ilet and had her fiancé take her back to the hospital.At the 2nd er visit she remained disconnected from the ilet while she received dextrose (d50).The patient reported keeping the ilet "in her hand and disconnected but kept it close to show the hospital staff her dexcom readings and trends." she reported being sent home around 5-5:30 am.She was advised to remain disconnected from the ilet until she could get in to see her endocrinologist.On (b)(6) 2023 around 11 am the patient was seen by her healthcare provider.The patient's insulin target was raised to higher, and she re-connected to the ilet.Later that day the patient's blood sugar went low again (58 mg/dl).The cds spoke with the patient again on (b)(6) 2203 at 4:17 pm, the cds advised the patient to remain disconnected from ilet.The patient could resume previous therapy - omnipod 5.The cds helped the patient down the ilet.The cds will be contacting the patient's healthcare provider on (b)(6) 2023 to discuss options of a factory reset, resuming with a higher target and re-training the patient in-person.The patient also has a history of lupus.

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.

• 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: 18068100
• MDR Text Key: 327320095
• Report Number: 3019004087-2023-00013
• Device Sequence Number: 1
• Product Code: QJI
• UDI-Device Identifier: 850050080015
• UDI-Public: (01)850050080015
• Combination Product (y/n): N
• 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: 11/03/2023

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: 10/24/2023
• Initial Date FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2023
• 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