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); Confusion/ Disorientation (2553)

Event Date 12/07/2023

Event Type  Injury  

Event Description

On 12/8/23 a beta bionics clinical diabetes specialist (cds) reported one of her patients experienced severe hypoglycemia last night (12/7/23).The patient's blood glucose (bg) got down to 43 mg/dl.The patient experienced symptoms of confusion and loss of cognitive functioning.The patient required her husband to inject her with glucagon and he called emts.The emt instructed the patient to eat bread.No dextrose or additional glucagon was given by the emt.The patient's blood glucose (bg) came up by the time the emts left, and she is now ok.The cds stated that an overtreatment of low bg contributed to the patient's hypoglycemic event.The night before while making dinner the patient's bg went into the 60s mg/dl and she consumed a rice crispy treat, a granola bar, and milk.The patient tends to have postprandial hypoglycemia if she doesn't slightly give herself a pre-meal bolus announcement.On 12/11/23 the cds followed-up and spoke with the patient.The cds looked at the patient's ilet log reports.The patient is having no additional hypoglycemia and states that she feels great.The cds provided education on appropriate treatment for a falling blood glucose (bg) of 75 and 54mg/dl.The patient agreed to consuming 15g of carbohydrates when she has low bg and waiting for her bg to come back up.The cds also provided education on meal announcement boluses.The patient is in good spirits and appreciated the additional education refresher.

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: 18320613
• MDR Text Key: 330401112
• Report Number: 3019004087-2023-00022
• 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: 12/13/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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