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 Problem Hyperglycemia (1905)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.The ilet logs were reviewed by beta bionics failure investigation department and noproduct performance issues were identified.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 12/15/2023 a beta bionics clinical diabetes specialist (cds) reported an ilet patient was hospitalized due to a severe hyperglycemic event.The patient started on the ilet on (b)(6) 2023.On (b)(6) 2023 the patient had dialysis.The patient reported he disconnected from the ilet during dialysis for three hours.After dialysis the patient reconnected to the ilet.The patient woke up sometime on (b)(6) 2023 with a blood glucose (bg) of 39 mg/dl.The patient stated he "panicked" and began eating large amounts of carbohydrates.The patient called ems and reported his bg rose to 800 mg/dl.The patient was admitted to the hospital early (b)(6) 2023 and was discharged late (b)(6) 2023.The patient stated he was not in diabetic ketoacidosis (dka) and received iv fluids and antibiotics for treatment during his stay.The patient did not wear the ilet during hospitalization.The patient stated during his low bg event he did not have a seizure or loss of consciousness/change in mental status.The patient stated his symptoms included sweating and shaking.The cds followed-up with the patient on (b)(6) 2023.The patient reported he was overtreating his low bg because he is used to having high bg and he gets very anxious.The patient also reported disconnecting from the ilet for long periods of time.The patient reported he is most consistent with eating lunch but also has missed some meal announcement boluses.The cds reviewed with the patient never treating for a low bg until he receives an alarm and then only treating with up to 15g (4 ounces of juice since juice is his preferred choose).The cds also reviewed keeping the ilet on during dialysis, never disconnecting for more than 1 hour, and the importance of announcing meal boluses and how to announce.The patient is back on the ilet and the cds will monitor the patient's progress closely.

• 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: 18448762
• MDR Text Key: 332159413
• Report Number: 3019004087-2024-00003
• 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: 01/04/2024

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: 12/15/2023
• Initial Date FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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